A Medical Device Daily

Monogram Biosciences (South San Francisco) reported that Pfizer (New York) has agreed to invest $25 million in Monogram and has entered into a non-exclusive collaboration agreement for Monogram's Co-Receptor Tropism Assay.

Pfizer will make the investment – expected to close this month – through a 3% senior secured convertible note, payable in May 2010.

Separately the companies reported signing a collaboration agreement in order to make Monogram's Co-Receptor Tropism Assay available for patient use on a global basis. The Co-Receptor Tropism Assay has been utilized in HIV/AIDS clinical trials for Pfizer's investigational CCR5 inhibitor drug candidate, maraviroc.

William Young, Monogram CEO, said, “In 2002, Pfizer made an equity investment in Monogram and since that time, we have provided sophisticated molecular diagnostic testing services and scientific assistance in the area of HIV drug resistance for many of Pfizer's HIV programs, including the ongoing Phase III maraviroc clinical development program.”

Alfred Merriweather, Monogram CFO, said, “At the end of the first quarter of 2006, we had $67 million in cash and investments. On a pro forma basis, including the anticipated proceeds of Pfizer's investment, these cash resources would be $92 million. This strengthening of our balance sheet gives us enhanced flexibility to address our business and financial opportunities and to facilitate Monogram's continued growth and development.”

The note will be issued on May 19, subject to the satisfaction of customary closing conditions, and will be due on May 19, 2010, unless converted earlier. The note will be convertible at Pfizer's option into Monogram stock at a conversion price, initially set at a 20% premium to the average closing price of Monogram stock during a specified period prior to the issuance of the note.

Monogram is advancing individualized medicine by developing products designed to help doctors optimize treatment regimens.

Uptake Medical (Seattle), a developer of medical technologies for the treatment of emphysema, reported receiving $9 million in a Series A equity funding.

New investors include Prism Venture Partners, which led the round, GBS Venture Partners, Onset Ventures, Affinity Capital and WRF Capital, the venture investment arm of the Washington Research Foundation. Seed investor Arboretum Ventures also participated in the round.

The company said that the financing will be used to fund preclinical development of its Bronchoscopic Lung Volume Reduction (BLVR) technology, as well as to build staff prior to clinical trials.

Uptake calls the BLVR device a next-generation interventional pulmonology approach to treating emphysema.

Robert Barry, CEO of Uptake, said: “We believe our therapy will ultimately improve patients' lung function in a safer, more cost-effective manner, making it widely accessible to the millions of emphysema sufferers in the U.S. living with this debilitating disease.”

According to the American Lung Association (New York), emphysema is the fourth leading cause of death in the U.S., affecting some three million people in this country and 16 million individuals worldwide. The company further says it is the only leading cause of death that is on the rise.

John Brooks, general partner, Prism Venture Partners, said that Uptake's system is “a safe and effective lung volume reduction treatment aimed at measurably improving lung function and patient quality of life, without the attendant risks and costs associated with surgery, endobronchial glues, valves and occluders. We expect this novel approach will allow numerous emphysema patients to achieve improved lung function and quality of life through a simple, safe and less invasive approach.”

John Brooks, general partner, Prism Venture Partners and Geoff Brooke, MD, managing director, GBS Venture Partners, have joined Uptake's board.

In other financing news:

• Cardica (Redwood City, California) reported completing the second development milestone for its X-Port Vascular Access Closure Device, an automated device used to close access openings in the femoral arteries after interventional vascular procedures, which it is developing with Cook (Bloomington, Indiana).

Achievement of the milestone triggers a $500,000 payment from Cook.

Cardica says that the advantages of the X-Port device include a simple user interface, the ability to place it through the same introducer sheath used for the interventional procedure for greater convenience and speed, scalability and lower cost of goods. In addition, X-Port is designed to be less invasive, with a minimal amount of foreign material placed in the vessel wall.

Cardica said it is now conducting preclinical studies to assess safety and preliminary efficacy of the X-Port.

Brian Bates, senior vice president, business development of Cook, said, “The number of interventional vascular procedures is growing, and there is a significant need for next-generation access closure devices. We believe Cardica's microclip technology, precision engineering and creative approach are contributing to an innovative design that could potentially have broad application.”

Cardica and Cook last December entered into an agreement to develop the X-Port device under which Cardica is responsible for design and preclinical development, which is being directed by a committee that includes representatives from both parties. Cook is responsible for clinical development and regulatory approval and has exclusive commercialization rights to market the device.

Cardica said that it so far has accomplished $1 million in product development milestones under the collaboration (Medical Device Daily, March 9, 2006) and could receive another $1 million upon completion of other development milestones. Also, Cardica is entitled to receive royalties on any future worldwide sales by Cook.

“In less than six months after initiating our collaboration with Cook, we have achieved two development milestones, demonstrating our ability to efficiently leverage our proprietary automated technology into additional minimally invasive surgical interventions,” said Bernard Hausen, MD, PhD, president and CEO of Cardica.

Cardica manufactures automated anastomotic systems for coronary artery bypass graft (CABG) surgery. By replacing hand-sewn sutures with automated systems, Cardica provides cardiovascular surgeons with rapid, reproducible anastomoses, or connections of blood vessels, a critical aspect of the CABG procedure.

Cardica's C-Port Distal Anastomosis System is marketed in Europe and the U.S. The PAS-Port Proximal Anastomosis System is marketed in Europe and Japan. Cardica also is developing additional devices to facilitate vascular and other surgical procedures.