Viamet, Novartis Fund Targeting Metalloenzymes in $200M Deal
By Catherine Hollingsworth, Staff Writer

February 23, 2010 (BioWorld Today) Viamet Pharmaceuticals Inc. signed a deal worth more than $200 million with the Novartis Option Fund to discover and develop metalloenzyme inhibitors of interest to the Swiss drugmaker.

Morrisville, N.C.-based Viamet said the Novartis agreement provides an opportunity to expand its Metallophile technology beyond the current development programs aimed at metalloenzymes involved in infectious disease and oncology.

Viamet did not disclose any further details about the Novartis deal. In fact, Viamet has been tight-lipped about even its unpartnered preclinical programs. The company has said that its programs are based on well-validated metalloenzymes.

Despite its efforts to stay under the radar, Viamet’s core technology has been “attracting attention” from interested companies, Neil Moore, vice president of business development, told BioWorld Today.

Viamet also has grabbed the attention of corporate investors, the Novartis Option Fund, part of the Novartis Corporate Venture Funds, and Lilly Ventures, which led an $18 million Series B financing round at Viamet last year (See BioWorld Today, July 8, 2009).

With the Series B funds, Viamet hopes to take its independent programs through proof of concept before looking for partners.

Many of the companies Viamet has been spoken with so far have their own metalloenzyme programs, CEO Robert Schotzinger told BioWorld Today.

The company’s Metallophile technology is used to optimize the metal-binding component of existing inhibitors, including currently marketed drugs. Viamet’s metal-binding approach potentially could be used “to resurrect failed compounds from failed programs” or to “make good programs even better,” said Schotzinger, former CEO of BioStratum Inc.

He added that Novartis is “looking to us to solve the metal-binding problem.”

About a third of known enzymes have metals such as zinc or iron associated with their structure or activity, making metalloenzymes a well-known class of drug targets. Lotensin (benazepril HCl, Novartis AG) and other angiotensin converting enzyme (ACE) inhibitors target metalloenzymes, as does Viagra (sildenafil citrate, Pfizer Inc.).

However, certain classes of drugs that target metalloenzymes tend not be selective enough and can inhibit unintended, related targets. Histone deacetylase inhibitors have had problems with selectivity and matrix metalloproteinase (MMP) inhibitors, a hot angiogenesis-based drug target in the 1990s and early 2000s, also has run into problems in the clinic.

British Biotech plc, of Wokingham, UK, suffered through several failed clinical trials with MMP inhibitor Marimastat in various types of cancer. Celltech Group plc and several big pharmas also stumbled with MMP inhibitors.

Viamet raised $4 million in a Series A financing to support preclinical development work, and prior to that it operated on about $500,000 in seed funding provided by Intersouth Partners, which incubated the company in its Durham, N.C. facilities.

The Series A funds allowed Viamet to find its own space and expand its team. (See BioWorld Today, June 11, 2007.)

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HistoSonics, Inc. Announces Series A Financing

January 4, 2010 (Ann Arbor, MI) HistoSonics, Inc. today announced it has secured $11 million in a Series A financing led by Venture Investors of Ann Arbor, Michigan and Madison, Wisconsin. Venture Investors worked closely with Fletcher Spaght Ventures, Hatteras Venture Partners, Early Stage Partners, and TGap Ventures to assemble an outstanding investment syndicate. The company (based in Ann Arbor) will use the capital to develop its Histotripsy technology, licensed from the University of Michigan and developed by scientists in the Department of Biomedical Engineering and the Department of Urology. Histotripsy is a non-invasive, image guided system that ablates tissue with robotic precision. The first clinical application will be treatment of Benign Prostatic Hyperplasia (BPH), a prevalent condition in senior men. The condition affects over two million men in the US and approximately 400,000 are treated surgically each year. The company founders and co-inventors of Histotripsy are Charles Cain, Ph.D., Brian Fowlkes, Ph.D., Tim Hall, Ph.D., Zhen Xu, Ph.D. and William Roberts, MD, all from the University of Michigan. Management co-founders are Tom Davison, Ph.D., Chairman & CEO of HistoSonics, M. Christine Gibbons, President & COO and Jim Bertolina, Ph.D., V.P. of R&D & CTO.

While most of ultrasound products on the market today use heat to destroy unwanted tissue, Dr. Cain and his colleagues took an alternative approach in using cavitation, or, the production of tiny energetic bubbles to create a surgical scalpel that liquefies tissues without heat. “The conventional wisdom was that cavitation should be avoided,” Cain says, “but no one could tell me why. So I decided to study it as a possible mechanism for non-invasive surgery.” Dr. Cain, with support from an outstanding team of U of M scientists (Drs. Fowlkes, Hall and Xu), and long-term funding from the National Institutes of Health, developed Histotripsy, a non-invasive form of therapeutic ultrasound that employs cavitation rather than heat to ablate tissues and uses ultrasound imaging to monitor the treatment in real time.

In collaboration with Dr. William Roberts of the U of M Department of Urology, Dr. Cain also obtained funding from the Coulter Foundation to develop Histotripsy as a method to treat BPH. With the support from the University’s Technology Transfer Office and other University resources the science attracted the attention of serial entrepreneur, Tom Davison, Ph.D. who was the co-founder of UltraCision and co-inventor of the Harmonic Scalpel and Shears, the most successful commercial device that employs therapeutic ultrasound technology (UltraCision and the Harmonic line were acquired by Ethicon EndoSurgery – J&J). “I was most impressed with the solid scientific foundation and broad platform potential to create a significant company based on Dr. Cain’s Histotripsy technology,” noted Davison. Dr. Davison was joined by Jim Bertolina, Ph.D. and Chris Gibbons to round out the founding management team. Ms. Gibbons was the Entrepreneur in Residence (EIR) at Venture Investors when she met Dr. Bertolina, who furthered her interest in HistoSonics. Ms. Gibbons explained, “The EIR program at Venture Investors was partially sponsored by the Michigan Venture Capital Association with the objective to help stimulate the Michigan economy by identifying venture investment opportunities where the EIR could become a part of the executive management team. I was drawn to the outstanding platform technology and large market opportunity at HistoSonics and I am delighted to be joining such an outstanding management and scientific team.”

“We think HistoSonics’ novel non-invasive ultrasound procedure has the potential to be a huge game-changer in treating BPH now and many other tumors in the future. They’ve assembled a great team to launch this product, and we’ve assembled a great syndicate of venture capital firms to fund and guide the Company to success,” stated Jim Adox, Managing Director and head of the Ann Arbor office for Venture Investors.

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Clinipace Acquires Worldwide Clinical Research, Inc. -
Company Expands to Enhance its Global Clinical Operations Capabilities and Therapeutic Practice Areas

November 9, 2009 (Morrisville, NC) Clinipace, global technology-driven clinical research organization (CRO), announced today that is has closed its acquisition of Worldwide Clinical Research, Inc. (WWCR), a Midwest-based CRO specializing in the management of clinical studies for biotechnology and pharmaceutical companies. With the acquisition, Clinipace has changed its name to Clinipace Worldwide, Inc.

Combined, the companies have managed over 70 contract research projects conducted at almost 3,000 sites with 100,000 patients. With specific expertise in oncology, among other therapeutic areas, the company will offer fully-integrated end-to-end technology-based clinical research solutions and services to growth-oriented and mid-tier biopharmaceutical and medical device firms.

WWCR currently provides core clinical operations functionality including monitoring, site management, and project management. These services will now be augmented by Clinipace's focus on technology-driven clinical research solutions to provide clients with full-service, global research services that result in greater trial visibility, more project control, and lower costs.

With the addition of more than 30 employees, the company headquarters will remain in Research Triangle Park, NC with additional domestic operations in Overland Park, KS, and South American operations based in Sao Paulo, Brazil, Buenos Aires, Argentina, and Lima, Peru. Clinipace has experienced triple digit growth over the past 12 months and is expected to continue to hire in all locations throughout 2010 to support its growing CRO business.

"Having honed our expertise on electronic data management services, we felt it was critical to expand both our clinical operations expertise and global presence in order to support our growth," said Jeff Williams, Clinipace CEO. "As one of the industry's most trusted CROs, WWCR's reliable service, global access to enrolling sites, and program-level therapeutic experience will be a natural complement to our existing research model and global expansion strategy.

Barbara Geiger, president and CEO of WWCR, will transition to Executive Vice President of Clinical Operations and will be responsible for directing all clinical operations for Clinipace Worldwide, Inc. from the Overland Park, KS office. Geiger brings over 25 years of experience in the conduct and management of Phase I-IV clinical trials and in the evaluation and selection of global clinical trial vendors. Prior to founding WWCR in 2000, she spent ten years at global CROs where she was Director of Project Management and Director of International Partners.

"By combining forces, we can better serve our clients with a fully-integrated end-to-end development solution and expert services," said Barb Geiger, Executive Vice President of Clinical Operations. "The synergies between WWCR and Clinipace will provide our clients with a complete range of technology-driven services, ranging from clinical operations all the way through regulatory submission."

About Clinipace Worldwide

Clinipace Worldwide is a global technology-driven clinical research organization (CRO) specializing in fully-integrated clinical research services for growth-oriented and mid-tier biopharmaceutical and medical device firms. Its team of therapeutic experts brings extensive investigator site selection, patient recruitment, clinical operations, data management, EDC software, biostatistics, and regulatory knowledge and insight into successful clinical development through proactive clinical trial management. With specific expertise in oncology, among other therapeutic areas, Clinipace Worldwide has managed over 70 contract research projects conducted at almost 3,000 sites with 100,000 patients. Clinipace Worldwide is headquartered in Research Triangle Park, NC with additional domestic operations in Overland Park, KS, and South American operations based in Brazil, Argentina, and Peru. For more information visit our website at clinipace.com.

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Hatteras Announces Significant Realizations in HVP II -
Trade Sales of B.R.A.H.M.S. and ESBATech Result in Full Return of Paid-in Capital to Limited Partners

October 8, 2009 (RTP, NC) Hatteras Venture Partners announced today that the recent sales of B.R.A.H.M.S. Holdings GmbH to Thermo Fisher Scientific for $470 million and ESBATech AG to Alcon, Inc. for $150 million upfront plus $439 million in clinical milestone payments has resulted in a full return of paid-in capital for Hatteras Venture Partners II, LP (HVP II, formerly Hatteras BioCapital Fund, LP). With this return of capital and the remaining thirteen investments in the fund, HVP II is one of the best performing venture capital funds in its class, as compared to the benchmarks for 2004 venture capital funds.

HVP II is the largest limited partner in HBM BioCapital (USD), LP, a significant shareholder in B.R.A.H.M.S. and ESBATech. HVP II invested $34.5M in HBM BioCapital (USD), LP in 2004 as a part of a partnership with HBM Partners of Zug, Switzerland, wherein Hatteras became an investment advisor to HBM BioCapital and a part of the private equity team for HBM BioCapital.

"This is a great outcome for Hatteras and all of the limited partners in Hatteras Venture Partners II," said John Crumpler, General Partner of Hatteras, "It is clear that our partnership with HBM will be a financial success. The fund is already one of the best performing venture funds of its vintage, and we still have 13 more investments that have not yet been realized."

About Hatteras Venture Partners

Hatteras Venture Partners is a venture capital firm based in Research Triangle Park, NC, with a focus on biopharmaceuticals, medical devices, diagnostics, and related opportunities in human medicine. Founded in 2000, the firm consists of an experienced team with a broad and complementary set of relationships skills in building successful new biomedical companies. In addition to co-founders Clay B. Thorp and John Crumpler, the general partners of Hatteras include Robert A. Ingram, Kenneth B. Lee and Douglas Reed, MD. The Hatteras Venture Partners team brings operational experience, a successful track record, and a proven ability to enhance the value of the companies in which it invests.

With three funds, the firm has more than $120 million under management. HVP I is a $3 million 2000 vintage fund focused on pre-seed and company formation opportunities. HVP II is a $35 million 2004 vintage fund focused on clinical stage opportunities through HBM BioCapital. Both HVP I and HVP II are among the best performing venture funds in their respective vintages. HVP III, an $83 million 2007 vintage fund focused on seed and early-stage opportunities in the southeastern United States, is building a portfolio of companies with breakthrough discoveries that impact human medicine. For more information go to: www.hatterasvp.com.

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Creating A Medical Device On The (Relatively) Cheap

August 31, 2009 (WSJ.com) Capital efficiency is key for venture-backed start-ups, especially those health care companies engaging in costly clinical trials. SpineAlign Medical Inc., which has launched a medical device in Europe on just $13.6 million, shows that a lot can be done with relatively little capital.

SpineAlign, which is developing a treatment for vertebral-compression fractures that commonly occur in osteoporosis patients, has kept outlays low by minimizing fixed costs, contracting out many services and keeping headcount low.

For example, SpineAlign, whose investors include Hatteras Venture Partners, MedFocus Fund and Wexford Capital, works with suppliers and service providers that take care of most of the jobs that would have been more costly to perform in-house. One key to this strategy is having good relationships with machine shops and other service providers so that they will take on your work promptly - even if you don't have the money to pay them right away, said SpineAlign Chief Executive Paul Chirico.

Start-ups also waste money when hiring initial employees, according to Chirico, who said he avoided recruiting fees by bringing aboard people he knew well. Today, SpineAlign has about 15 employees.

"Time is money in a start-up environment," he said. "If you waste three or four weeks looking for the right person, it's more costly than the person itself."

These efforts have helped Chirico avoid the fate of many start-up executives who build up infrastructure more than needed early on, thinking it will impress investors.

"They want to look good," he said. "They want to be able to walk people around and show them great facilities. That's not what moves the ball forward - why have a clean room that sits idle three weeks out of the month?"

When the company started four years ago, "We were dealing with a blank sheet of paper," said Chirico. SpineAlign, which doesn't yet have a working Web site, has just launched U.S. clinical studies that could lead to 510(k) clearance in 2010.

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Embrella Cardiovascular, Inc. Announces Final Closing of Series B Round

August 14, 2009 (Wayne, PA) Embrella Cardiovascular, Inc., a private company developing the next generation of embolic protection devices for use during coronary procedures, today announced the final closing of its Series B financing round, raising a total of $6.7 million in new capital.

The financing was led by BioStar Ventures and the MedFocus Fund who assembled a strong syndicate of investors, including new investments by Edwards Lifesciences Corporation and Hatteras Venture Partners. In conjunction with this closing, Douglas Reed, M.D., General Partner of Hatteras Venture Partners, will join the board of directors of Embrella.

Proceeds of the Series B financing will fund Embrella to key inflection points. "This capital will allow the company to complete the European Clinical trials and submit our results to European Regulatory Authorities with the intent of achieving CE Mark approval," said Mr. Jeffrey O'Donnell, Embrella's CEO. "Once this is achieved, we would then be approved to commercialize our device in the EU."

Embrella Cardiovascular, Inc., is developing an embolic protection device called the Embrella Embolic Deflector. The device is designed to prevent dangerous debris or emboli from entering the brain by deflecting the emboli away from the carotid arteries. These dangerous emboli can cause neurological complications during cardiovascular procedures.

The Embrella Embolic Deflector will serve as an adjunctive device to be used in procedures such as the less invasive Transcatheter Aortic Valve Implantation (TAVI) procedure. This technology is currently approved in Europe for high risk patients with severe aortic stenosis. Frequently the aorta contains atheromatous plaque and the valve can be densely calcified. During TAVI, wires, catheters and balloons pass over the aortic arch where they may dislodge debris and calcific particles. Unless deflected from the arteries leading to the head, such debris may embolize to the brain and cause stroke. "The Embrella Deflector is an elegant device that we believe will significantly improve the safety of transcatheter valve replacement procedures," Dr. Reed commented.

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SpineAlign Medical Treats First Patient in U.S. with New, Innovative System for Vertebral Compression Fracture Repair

July 23, 2009 (San Jose, CA) SpineAlign Medical, Inc. (formerly SpineWorks Medical, Inc.) announced today the successful treatment of the first patient in its FDA Investigational Device Exemption (IDE) feasibility study. The SpineAlign System is designed for the treatment of vertebral compression fractures and features an innovative nitinol implant designed to achieve vertebral body reconstruction via a transpedicular, minimally-invasive approach.

“We had an excellent outcome with the SpineAlign device – the patient’s pain scores dropped dramatically within 24 hours and we achieved good central fracture reduction, said Bohdan Chopko, M.D., Ph.D., clinical faculty member at Northeastern Ohio Universities College of Medicine and practicing neurosurgeon at Mid-Ohio Neurosurgical Care, Mansfield, Ohio. “Both my patient and I were excited to participate in the U.S. introduction of this cutting edge technology. The SpineAlign System shows great promise for the treatment of vertebral compression fractures and the restoration of vertebral anatomy.”

“We are very pleased to have achieved this major milestone, which marks the initial phase of our clinical program in the United States”, said Paul Chirico, President and CEO of SpineAlign Medical. “Combined with the product’s successful commercial debut in Rome two weeks ago at the ASSR/ESNR joint conference, the clinical introduction of the product in the U.S. demonstrates that the company’s momentum is beginning to build.”

Since receiving the CE Mark in the fall of 2008, SpineAlign Medical has successfully treated more than 50 patients at several centers of excellence in Europe, and is beginning an aggressive EU commercial launch.

About SpineAlign

The SpineAlign device represents the first of many new innovations in the area of minimally invasive percutaneous vertebral body reconstruction to come from SpineAlign Medical. The SpineAlign device is a vertebral body implant designed to treat fractures in the thoracic or lumbar spine in patients suffering from osteoporosis. The SpineAlign Implant is an expandable metal device composed of a nickel-titanium (Nitinol) alloy that provides internal scaffolding to engage the vertebral body endplates, maintaining lift until bone cement is injected. SpineAlign is available in two shapes and a range of sizes to address different anatomical needs for the treatment of vertebral compression fractures. Bone cement provides the long-term load bearing support. Prior to injection of bone cement, the SpineAlign Implant is fully retrievable for repositioning or complete removal. The SpineAlign device is not yet available for sale in the United States and is currently in clinical evaluation to support its 510(k) filing with the FDA.

SpineAlign Medical, Inc., is an early-stage medical device company dedicated to the design, development and successful commercialization of minimally-invasive products for spine procedures.

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Viamet Pharmaceuticals secures $18M financing

Company to Advance Development of Novel Metalloenzyme Inhibitors and Proprietary Metallophile™ Technology Platform

July 7, 2009 (Research Triangle Park, NC) Viamet Pharmaceuticals, Inc. announced today that it has secured $18 million in a Series B financing to accelerate the development of its novel metalloenzyme inhibitors and to advance its Metallophile™ Technology platform. The proprietary Metallophile™ Technology is based on Viamet's world-class expertise in bioinorganic chemistry and metalloenzymes and allows Viamet to rapidly and cost-effectively generate "best-in-class", novel compounds by optimizing the metal-binding component of existing metalloenzyme inhibitors. The investment was led by the Novartis Option Fund and Lilly Ventures and also included Viamet's existing investors Intersouth Partners, Hatteras Venture Partners, Lurie Investment Fund, and Astellas Venture Management. As part of the closing of the financing, Lauren Silverman, Ph.D., Managing Director of the Novartis Option Fund and Ed Torres, Managing Director, Lilly Ventures, have joined Viamet's board of directors.

"We are very pleased that the Novartis Option Fund and Lilly Ventures have elected to invest in Viamet. Their interest in our pipeline programs and Metallophile™ Technology is truly gratifying," said Robert Schotzinger, M.D., Ph.D., President and Chief Executive Officer of Viamet. "Both the Novartis Option Fund and Lilly Ventures share a common vision with us and our current investors that the Metallophile™ Technology platform will significantly improve many existing inhibitors of key metalloenzymes through enhanced safety, efficacy and pharmacokinetics."

Lauren Silverman, Ph.D. commented, "We believe that Viamet's Metallophile™ Technology has the potential to dramatically improve the selectivity of existing metalloenzyme inhibitors leading to reduced off-target toxicities and improvements in the therapeutic index of this important class of drugs. The strength of the technology and team at Viamet was particularly attractive to us and we are excited to be part of their effort moving forward."

Ed Torres added, "Metalloenzymes are well-recognized targets for therapeutic intervention. Viamet's Metallophile™ Technology represents a paradigm shift that has the potential to deliver markedly improved inhibitors of this large and commercially validated class of enzymes. Lilly Ventures invests in companies with promising technologies that have the potential to generate multiple, "best-in-class" products and we believe that Viamet represents just such an opportunity."

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Pathfinder Hires Medical Device Veteran as CEO

Company Enters Commercial Phase with Product Launch at the American Hepato-Pancreato Billary Association (AHPBA) Conference

March 11, 2009 (Nashville, TN) Pathfinder, a medical device company with first to market products for "Surgical GPS" of the abdomen, announced that it has hired Skip Goode as President and CEO effective immediately. As head of Sales for leading edge companies including Medtronic Surgical Navigation, Accuray, and EndoGastric Solutions, Mr. Goode played a pioneering role in key product launches and sales efforts for innovative capital equipment and disposable tools in the surgical oncology field. Mr. Goode takes the helm in advance of the AHPBA conference where Pathfinder will launch its two FDA-cleared products for pre-operative planning and intra-operative navigation of liver surgery.

"We conducted an exhaustive, nationwide search to find the best leader for Pathfinder," said Clay B. Thorp, General Partner, Hatteras Venture Partners and Chair of the Board and search committee for Pathfinder. "Skip brought the right blend of experience, character, and vision. Having led sales in highly successful companies in our field, we felt he was ready to take his skills to the next level as CEO of Pathfinder."

"I am thrilled with the opportunity to lead Pathfinder," said Skip Goode, President and CEO of Pathfinder. "The engineering and scientific teams have done a terrific job of designing, building, and gaining FDA clearance for the first system for surgical planning and intra-operative navigation of liver surgery. Now, we have a great opportunity to introduce these systems to hospitals across the country. Pathfinder's ability to increase the number of operable liver cancers and improve the confidence of liver surgeons has the potential to save lives and drive significant economic benefits for health care."

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Pathfinder Lands $5 Million Series A Round

Financing Led by Hatteras Venture Partners Helps Launch the First System for Surgical Guidance in the Abdomen

October 30, 2008 (Nashville, TN) Pathfinder Therapeutics, Inc. (PTI), a medical device company focused on the development of "surgical GPS" systems for the abdomen, announced that it has closed on a $5.2 million Series A financing round led by Hatteras Venture Partners of Research Triangle Park, NC. Other investors included Florida Gulfshore Capital, Clayton & Associates, Nashville Capital Network, Lumira, and Vanderbilt University. Concurrent with the financing, Clay Thorp and Bob Morff, PhD, from Hatteras Venture Partners and Richard Molloy from Florida Gulfshore Capital have joined the Board of Pathfinder, and Bob will serve as interim CEO.

"After speaking with dozens of surgeons and thought leaders around the world, we are confident that Pathfinder will fill a critical void for modernizing surgical precision in the exploding field of robotic and image guided surgery," said Clay B. Thorp, General Partner, Hatteras Venture Partners. "As a first mover with strong intellectual property and some of the best thought leaders in the field, we believe that Pathfinder is well-positioned from a strategic and marketing point of view."

New capital will finance the launch of PlaniSight Linasys and SurgiSight Linasys, medical devices focused on the planning and intra-operative navigation of liver surgery. SurgiSight Linasys, an integrated system of hardware, software, and proprietary tracked tools, received FDA 510(k) clearance in December 2007. PlaniSight Linasys, a software system for pre-operative planning for liver surgery, received FDA 510(k) clearance in September 2008. The company is currently conducting a post-clearance clinical trial for Linasys, funded by a SBIR grant from the National Cancer Institute. Sites for the trial are the University of Pittsburgh Medical Center, the Memorial Sloan Ketttering Cancer Center, and the University of Florida Health Science Center. Pathfinder's products will be formally launched at the American Hepato-Pancreato-Billary Association (AHPBA) meeting in Florida in March 2009.

"This investment allows the translation of our research and development from the laboratory to the hospital and now to the marketplace where it can help the maximum number of patients," said Robert Galloway PhD, co-founder and Professor of Biomedical Engineering at Vanderbilt University. "Our team of engineers and surgeons at Vanderbilt has been a leader in system development for surgery and other forms of therapeutic guidance beginning with brain surgery. We are now able to bring the advantages of such guidance to the liver, kidney and other abdominal organs."

"Vanderbilt has nurtured and developed Pathfinder for several years," said Harry Jacobson, MD, Vice Chancellor for Health Affairs at Vanderbilt University Medical Center. "We are pleased to have a firm of the caliber of Hatteras join us in helping Pathfinder enter this next phase as an independent, entrepreneurial success."

About Pathfinder Therapeutics, Inc.

Pathfinder Therapeutics, Inc. is a medical device company dedicated to increasing the number and effectiveness of surgeries on abdominal and other soft tissue organs. Pathfinder improves surgical precision by allowing surgeons to "see through" the organ they are operating on by registering the surgical instrument in three-dimensional space onto pre-operative patient medical images. Pathfinder is the first company to receive FDA clearance for a medical device to navigate liver surgery using preoperative medical images, SurgiSight Linasys. SurgiSight Linasys uses state-of-the-art line of sight localization and laser range scanning surface registration techniques to show surgeons where they are in the context of their target organ and underlying structures. In addition to SurgiSight, Pathfinder sells PlaniSight Linasys, a software system for liver surgery planning. Beyond the liver, Pathfinder is developing guidance systems for the kidney, pancreas, and other organs. For more information go to: www.2pti.com.

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Craig Rosen, Biopharmaceutical Development Expert, Joins Phase Bioscience as Executive Chairman

October 9, 2008 (Morrisville, NC) Phase Bioscience, Inc., a development stage biopharmaceutical company, announced today that Dr. Craig Rosen has joined the company as Executive Chairman of the Board, effective immediately.

"I have long been interested in versatile technology platforms that can create a pipeline of products addressing improved pharmacology, safety and delivery, all at an attractive cost of goods," commented Dr. Rosen. "Based on elastin-like polypeptides (ELPs), this technology provides the highest potential and versatility that I have seen to date based on its wide application to peptides, proteins and small molecule drugs. From my many years of product development experience, I am confident that the technology developed by PhaseBio can deliver exciting therapeutics across numerous therapeutic disciplines to address significant unmet needs."

"With a truly impressive track record in product development and innovation, Craig Rosen is amongst the most accomplished and successful biotechnology executives in the world," noted Dr. Chris Prior, CEO of PhaseBio. "We can unequivocally say that PhaseBio has assembled a premiere protein engineering/product development team. We are already in preclinical development with greatly improved versions of existing product candidates all directed towards large markets in diabetes, cancer and blood disorders. I could not be more excited about our future."

Prior to joining PhaseBio, Dr. Rosen was Senior Vice President and Chief Scientific Officer at Teva Biopharmaceuticals, USA and remains a consultant for the company. He was also the Co-Founder, Chief Scientific Officer and Executive Chairman of CoGenesys before its acquisition by Teva Pharmaceuticals earlier this year. Prior to founding CoGenesys, Dr. Rosen was President and Chief Scientific Officer of Human Genome Sciences as well as a scientific founder and member of their Board. Dr. Rosen has served on several corporate boards as well as the American Foundation for AIDS Research (AmFAR) and the Scientific Advisory Boards for the Institute of Human Virology and the Wistar Institute.

PhaseBio successfully recruited Dr. Prior and other key scientists to the company earlier this year, paving the way for rapid growth. Collectively, the team members have deep experience in designing and conducting clinical trials and are responsible for thirty seven INDs as well as numerous NDAs and product approvals.

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SpineWorks Medical, Inc. Announces CE-Mark for SpineAlign™ Vertebral Body Replacement System

July 15, 2008 (San Jose, CA) SpineWorks Medical, Inc. announced today that it received CE-Mark authorization for commercialization of its SpineAlign™ Vertebral Body Replacement (VBR) System in the European Union and all countries recognizing the CE-Mark. The SpineAlign VBR is SpineWorks Medical’s first approved product that was designed for a transpedicular, minimally-invasive approach to vertebral body reconstruction and anterior spinal column support.

The SpineAlign VBR was subjected to a series of ASTM tests conducted in accordance with the FDA “Guidance for Industry and FDA Staff: Spinal System 510(k)s” document issued May 3, 2004. “We completed all of the recommended biomechanical testing in compliance to the VBR guidance standards and exceeded all recommended loads,” stated Paul Chirico, President and CEO for SpineWorks Medical. “Our product development process has incorporated a diligent approach of keeping an eye on the biomechanics that are needed to accomplish this exciting new approach to reconstructing disease and age compromised vertebral bodies.”

“In the delivery of care for spinal diseases, physicians are always looking for more innovative technologies -- especially those that utilize the latest generations of medical imaging to deliver more effective therapies,” said Sean Pakbaz, MD, Associate Professor of Radiology and Neurointerventional Surgery at the University of California San Diego Medical Center and consultant to SpineWorks Medical. “The SpineAlign device which has surpassed our expectations in both laboratory and cadaveric testing allows us to work directly through the spine vertebral body pedicle, while at the same time minimizing soft tissue disruption. To reconstruct a vertebral body is becoming easier, both for us, and for the patient.”

The SpineAlign device represents the first of many new innovations in the area of minimally invasive percutaneous vertebral body reconstructions to come from SpineWorks Medical. The treatment of spine disease is rapidly moving from open surgery toward less tissue disruptive procedures with the use of better imaging and innovative, minimally invasive devices.

SpineWorks Medical, Inc., is an early-stage medical device company dedicated to the design, development and successful commercialization of minimally-invasive products for spine procedures. SpineWorks Medical currently has products under review by the FDA and anticipates having several CE-Marked products cleared for European commercialization by the end of 2008.

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Hatteras Announces Its Scientific Advisory Board

Genentech Founder, Herb Boyer, to Serve as Chair

May 20, 2008 (Durham, NC) Hatteras Venture Partners announced today the establishment of its Scientific Advisory Board (SAB). The Board of internationally renowned scientists and industry experts is focused on helping Hatteras identify trends and opportunities in the fields of biopharmaceuticals, medical devices, diagnostics, and related areas of life science innovation.

"We are thrilled with the quality and caliber of the advisors we have recruited to help us build the next generation of successful life science companies," said Bob Ingram, General Partner of Hatteras Venture Partners. "We are particularly pleased that Herb Boyer has agreed to serve as Chair of our scientific advisory board."

The Hatteras SAB consists of eight scientists and industry experts from each of the fields of interest to Hatteras and will be chaired by Herb Boyer, Ph.D., one of the founders of Genentech. Dr. Boyer is the co-inventor of recombinant DNA technology, which serves as the basis for all recombinant protein therapeutics. The full Hatteras SAB consists of:

    Herb Boyer, Ph.D., Co-Founder of Genentech, Professor Emeritus of Biochemistry and Biophysics, University of California, San Francisco
  • James Powell, M.D., pathologist, founder of LabCorp and Tripath
  • Charlie Sanders, M.D., cardiologist, former CEO of Glaxo and former Head of Massachusetts General Hospital
  • Lucy Shapiro, Ph.D., Professor of Developmental Biology and Director of the Beckman Center for Molecular and Genetic Medicine, Stanford University; Co-Founder of Anacor Pharmaceuticals
  • Thomas Mac Mahon, Chairman and former CEO of LabCorp
  • Arnold Levine, Ph.D., Professor of Systems Biology, Institute for Advanced Study, former President and CEO of Rockefeller University
  • Beat Merz, Ph.D., medical device expert, industry and investing veteran, Investment Advisor, Trigon Medical
  • Kazumi Shiosaki, Ph.D., Managing Director, MPM Capital, former SVP of Drug Discovery, Millennium Pharmaceuticals

"I have been truly impressed by the vision and ethics of the Hatteras team," said Dr. Boyer. "The quality of the science coming from the southeast is impressive, and Hatteras has a tremendous opportunity to translate these innovations into world-class companies with transformational products."

"Hatteras has a strategic focus on investment opportunities emanating from institutions in the southeast," said Ken Lee, General Partner of Hatteras Venture Partners. "We wanted to assemble an advisory board of some of the best minds in our industry to ensure that all opportunities are 'best of breed' on an international basis."

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Leading Protein Engineering Executive Joins Phase Bioscience as CEO

April 15, 2008 (Research Triangle Park, NC) Phase Bioscience, Inc., a development stage biotechnology company, announced today the appointment of Christopher Prior, Ph.D. as Chief Executive Officer and Member of the Board of Directors.

"Based on my industry experience, this unique protein engineering technology will create novel therapeutics as well as improve existing products' safety, efficacy and convenience of use. These elastin-like biopolymers are applicable to proteins, peptides and small molecule therapeutics," said Prior. "The technology combines improved production efficiency and better pharmacology in one step which are major hurdles in biopharmaceutical drug development."

Most recently, Dr. Prior was Founder, President and Chief Scientific Officer of BioRexis Pharmaceuticals which was acquired by Pfizer in 2007. Dr. Prior was also the Founder and President of Principia Pharmaceuticals and a Senior Executive at Human Genome Sciences after its acquisition of Principia. He is a proven serial entrepreneur, fund raiser, and prolific inventor. Dr. Prior's success in developing and implementing business development strategies has resulted in the completion of two acquisitions since 2001, generating significant returns to investors.

"We are thrilled to welcome Chris as the new leader of PhaseBio," said Clay Thorp, Chairman of Phase Bioscience. "His successful track record in developing the albumin and transferrin protein scaffolds is unparalleled. We are particularly excited that several key members of Chris' team at BioRexis will be assuming scientific leadership roles at PhaseBio. We are confident that Chris and the management team will enable the company to move our technology aggressively forward as the new biologics platform for recombinant products."

Dr. Prior has more than 20 years of experience in the development of biopharmaceuticals, involving more than 20 INDs, four NDAs, and three product approvals. Before Principia, Dr. Prior was General Manager of The Immune Response Corporation, Director of Research and Development (biologics) for Rhône Poulenc Rorer (now Sanofi-Aventis), Director of Product Development at Invitron Corporation and a Senior Scientist at Biogen. Dr. Prior received a B.Sc. (honours) in chemistry from the University of London, obtained his Ph.D. in biochemistry from Columbia University and was a post-doctoral research fellow at The Rockefeller University. Dr. Prior is the author of numerous publications and patents.

About Phase Bioscience, Inc.

Phase Bioscience, Inc. (PhaseBio), located in Research Triangle Park, NC, is a privately held protein engineering company focused on developing the next generation of biopharmaceuticals. The company's versatile technology is based on biopolymers of elastin-like repeating subunits to which drugs can be attached or peptides and proteins genetically fused, enhancing therapeutic activity. Alternatively, the biopolymer can be uniquely engineered to undergo a phase transition facilitating a reversible depot formulation for a sustained release mechanism of action.

This same technology platform can be used to improve protein expression and rapid purification in a single step, deltaPhase process.

PhaseBio investors include Fletcher Spaght Venture Partners, Hatteras Venture Partners and Johnson and Johnson Development Corporation.

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ArtusLabs Closes $2.6 Million in Series A Funding

April 8, 2008 (Durham, NC) ArtusLabs, a leading provider of life science software tools and data management solutions, today announced that the company has closed a $2.6 million round of venture financing. The Series A round was led by Hatteras Venture Partners and Southern Capitol Ventures.

ArtusLabs was founded by the award-winning management team that built Sythematix, the software solutions company that pioneered the Enterprise Electronic Lab Notebook marketplace and was eventually acquired by Symyx Technologies, Inc. (NASDAQ: SMMX) in 2005.

"We are thrilled to partner with Robin Smith and Brian Ballard to build the next generation research informatics company," said Clay B. Thorp, General Partner, Hatteras Venture Partners. "Robin and Brian have assembled the same world-class team that we built with Synthematix.  ArtusLabs is demonstrating the ability to generate rapid value by focusing this proven team of people on this tremendous pain-point in research informatics."

ArtusLabs's technology platform, Ensemble, has the potential to significantly reduce the research and development time a pharmaceutical or biotech organization spends discovering and developing novel therapeutic compounds. The company will use the funding round to invest and expand its technology platforms breadth of service, expand ArtusLabs marketing efforts and to fund new product development initiatives.

"A competitive marketplace has put intense pressure on life science companies to better streamline costs and increase operating efficiencies," said David Jones, a principal at Southern Capitol Ventures. "ArtusLabs has developed software solutions with the latest Web 2.0 technologies that directly address these challenges. The company's innovative technologies and outstanding management team makes it a very attractive addition to our portfolio."

"We are all very excited to be working again with this group of investors," said Robin Y Smith, CEO of ArtusLabs. "There is a growing pain-point in the life science industry when it comes to software solutions. From outdated platforms to obtuse licensing schemes, ArtusLabs was created to reinvent the way a life science enterprise uses its organizational data assets."

About ArtusLabs

ArtusLabs is a technology company which is delivering scientific data management software and services designed to enhance workplace collaboration and accelerate the rate of drug discovery.  ArtusLabs was founded by the same proven team that formed Synthematix, the start-up that pioneered the Enterprise Electronic Lab Notebook marketplace.  This leadership team has extensive expertise in processing, mining and managing complex scientific data and information generated from research activities.  The company's flagship product, Ensemble for Life Science, is a unique software solution for organizing data.  It blends social networking, personal publication, and refined data mining to both internal and external research communication and management. For more information visit www.artuslabs.com

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Clinipace Raises $2.6 Million Series B

January 17, 2008 (Research Triangle Park, NC) Clinipace, a clinical research software company based in the Research Triangle Park, announced today that it has closed a $2.6 million Series B financing round led by Hatteras Venture Partners, a life sciences focused venture firm based in Durham, NC, with participation by existing investors Brook Private Equity Advisors of Boston, MA and Emergent Growth Fund of Gainesville, FL.

Clinipace plans to use the capital for company expansion, with an emphasis on bolstering sales and marketing to accelerate growth. Since Clinipace's inception in 2004, the company has made steady strides in the clinical research market by focusing on underserved markets and by providing a more cost-effective and efficient means to support clinical processes via Tempo, Clinipace's unique clinical workflow engine. Clinipace's innovative workflow approach enables its clients to specifically address a wide variety of needs, from clinical trial data collection and management, to monitoring to tracking investigator initiated trials and reporting. The solution also enables Clinipace to run a more efficient operation - creating savings that Clinipace passes on to its customers.

John Crumpler, co-founder and General Partner of Hatteras Venture Partners cites this innovation and market expertise as he explained their decision to invest in Clinipace: "Clinipace has a satisfied customer base and has done a tremendous job of growing the business organically. These customers have validated the need for simple-to-use, flexible, and cost-effective software for clinical research and associated processes. We think that Clinipace has a great opportunity and a solid team with deep industry expertise that has proven it can execute. We are excited about working with Clinipace during this exciting growth phase."

Jeff Williams, CEO and co-founder of Clinipace, says his team is equally pleased to be working with Hatteras Venture Partners. "Hatteras is an ideal partner for us because they have deep experience and expertise in the life sciences and pharmaceutical industries; they really understand clinical research, our customers, and what it takes to successfully market products in this space." Williams continues, "The Clinipace team was really impressed by their due diligence as well; Hatteras carefully took the time to understand how each member of our team works, and why we have certain measures and dynamics in place. We felt like Hatteras really understood the values and work ethics that make us successful and our customers happy."

About Clinipace:

Clinipace is a clinical research software company providing a single, integrated data capture and study management platform for clinical research and registries conducted by biopharmaceutical and medical device companies, Clinical Research Organizations (CROs) and Academic Medical Centers (AMCs). Our platform, called Tempo, is delivered via a web-based, on-demand architecture that streamlines the clinical research process by eliminating the integration headaches associated with multiple platforms, reducing project efforts and costs from startup to conclusion, and empowering project stakeholders to make informed real-time decisions regarding their research. For more information on Clinipace, please visit: www.clinipace.com

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Phase Bioscience Announces Series B Investment from Johnson & Johnson Development Corporation, Fletcher Spaght Ventures and Hatteras Venture Partners


October 24, 2007 (Durham, NC) Phase Bioscience, Inc., a development stage biotechnology company, announced today that it has successfully raised an additional $5.4 million in Series B financing, bringing the total Series B round to $6.6 million. New investor, Fletcher Spaght Ventures (FSV) co-led the round, joining Series B lead investor, Johnson & Johnson Development Corporation (JJDC), which closed on a first tranche of the financing in December 2006 and invested further in this closing. Founding investor, Hatteras Venture Partners (HVP), reinvested in this Series B round from its new fund. Dr. Guy Fish, Vice President, FSV commented that "biopharmaceutical companies highly value the capabilities of PhaseBio's innovations."

The company's technology, in part licensed from Duke University, has the potential to significantly reduce the costs and timelines associated with the purification of therapeutic proteins. In addition, the technology will greatly improve the delivery characteristics of pharmaceutical products. "This is a significant milestone for the company and provides the financial resources needed to continue the development and commercialization of the company's core technologies," said Nick Ellis, PhD, President and CEO of Phase Bioscience, Inc.

In conjunction with the financing, Guy Fish, MD, Vice President, FSV and Doug Reed, MD, General Partner, HVP join the Phase Bioscience Board of Directors. "Our new Directors bring invaluable experiences and perspectives to help lead PhaseBio through our next stages of growth," said Clay Thorp, Chairman of Phase Bioscience and HVP General Partner. Dr. Fish has over twenty years of experience in the life sciences, healthcare and biotechnology sectors. He serves as a Vice President in the Healthcare Practice Group at Fletcher Spaght, the firm's consulting business. Previously, Dr. Fish held an operating position at Collagenesis, was a senior member of The Boston Consulting Group and served as a securities analyst in the medical devices group of Sanford Bernstein. He holds an MD degree from the Yale School of Medicine and is board certified in Internal Medicine. He received an MBA from the Yale School of Management and an AB degree in Biochemistry from Harvard College. Dr. Reed has had a successful thirteen year record in the venture capital business at the Vector Fund and SR One. In addition, Dr. Reed has held business development positions at Geltex and NPS Pharmaceuticals. He practiced as a radiologist at Yale and the University of Washington and received an MBA from The Wharton School of Business.

About Phase Bioscience, Inc.

Phase Bioscience, Inc. (PhaseBio), located in Research Triangle Park, NC, is a privately held biopharmaceutical company molded around an innovative set of technologies that provide new solutions to delivery, production and purification of both protein-based therapeutics and small molecules. Our proprietary Elastin-Like Peptide (ELP) technology enables the Company and its partners to efficiently express and purify proteins and dramatically improve their pharmaceutical attributes. The Company's deltaPhase process for biologic purification eliminates expensive chromatography and ELP mediated drug delivery can turn a good drug into a great one.

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Viamet Pharmaceuticals Raises $4 Million Round of Financing


Drug Discovery and Development Company Focused on Metalloenzymes Closes Series A Round

June 7, 2007 (Research Triangle Park , NC) Viamet Pharmaceuticals Inc., a biotechnology company targeting metalloenzymes in the fields of infectious disease, inflammation and oncology, announced today that it has closed a $4 million Series A financing round.

The financing was co-led by new investor Hatteras Venture Partners and founding investor Intersouth Partners, which previously provided seed funding for the company. Douglas Reed of Hatteras Venture Partners will join Garheng Kong of Intersouth Partners on the company's Board of Directors.

"This Series A financing will support the rapid development of our metalloenzyme inhibitor programs," said Robert Schotzinger, M.D., Ph.D., President and CEO of Viamet Pharmaceuticals. "We look forward to working with our financial partners as we continue to grow the company."

"Having worked with Viamet since its founding, we're very pleased to see the company reach this important milestone," said Garheng Kong, M.D., Ph.D., of Intersouth Partners. "The technology is promising and there are significant market opportunities being pursued."

"Viamet is an exciting investment opportunity," said Douglas Reed, M.D., of Hatteras Venture Partners. "We believe the science creates new market opportunities and we look forward to working with Viamet to develop these interesting and important compounds."

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Hatteras Announces Initial Closing of Fund
Focused on Early-Stage Companies in the Southeast

Robert Ingram, Former CEO of GlaxoWellcome, Joins Hatteras

February 9, 2007 (DURHAM , NC) Hatteras Venture Partners announced today the first closing of its third venture capital fund, Hatteras Venture Partners III, LP (HVP III). The Fund has secured commitments for $60 million to invest in seed and early-stage companies in biopharmaceuticals, medical devices, diagnostics and related opportunities in human medicine. The ultimate fund size is expected to be $100 million. HVP III may invest in opportunities throughout the country but will focus on forming and leading companies in the southeastern United States , where the level of National Institutes of Health-funded research is high but the availability of early-stage venture capital is limited.

For its third fund, Hatteras has recruited Robert Ingram, former CEO of GlaxoWellcome and vice chairman pharmaceuticals for GlaxoSmithKline, and Douglas Reed, M.D., a 13-year venture capital veteran, to join Hatteras as general partners and members of the Fund's Investment Committee.

“I am thrilled to join a great group of partners at Hatteras,” said Ingram, who has served as an advisor to the firm. “We will work hard to catalyze the next wave of breakthrough improvements in medicine by commercializing products, based on the billions of dollars of basic research conducted at the outstanding universities in the Southeast.”

“When you analyze the different regions of the country, you see significant federal and private research dollars flowing into laboratories in the Southeast,” said HVP General Partner Clay Thorp. “At the same time, venture capital flows into southeastern companies are much lower than in California and Massachusetts . This capital gap represents a tremendous investment opportunity.”

Hatteras Venture Partners was founded in 2000 by John Crumpler and Clay Thorp with the launch of its first venture capital fund, Hatteras Venture Partners I, a pre-seed fund that has generated top decile returns focused predominantly on company formation in the life sciences. In 2004, the firm added Ken Lee, former head of International Life Science at Ernst & Young, and Dana Fowlkes, M.D. Ph.D., a scientist and successful serial entrepreneur, and raised its second fund, Hatteras Venture Partners II, a later-stage fund invested through a partnership with HBM BioCapital.

     
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