Sadra Medical (Campbell, California) said it has raised $30M in new investment capital, money it hopes will help push its Lotus Valve System for percutaneous aortic valve replacement (PAVR) toward a CE mark.
The round was led by Accuitive Medical Ventures, and includes existing investors Boston Scientific, Finistere, Firstmark Capital, Oakwood, ONSET Ventures, and SV Life Sciences.
During a PAVR procedure, a valve prosthesis can be positioned in a patient's heart by means of a catheter navigated through the patient's arteries, Sadra said. PAVR allows a diseased aortic valve to be replaced with a minimally-invasive procedure, thus eliminating the trauma, long recovery times, and attendant risks of open-heart surgery, the company noted.
President/CEO Ken Martin told Medical Device Daily that the Lotus is a second-generation PAVR product, saying its primary benefit over first-generation products is that it is repositionable. This means that if the interventional cardiologist has more precise control over the placement of the prosthesis.
That's not the case with first-generation devices, he said.
"Because of the limitations of first generation systems – currently in use at specially trained hospitals in Europe and the U.S. – PAVR remains an exacting, challenging procedure requiring great technical skill, and the clinical outcomes vary greatly," said Charles Larsen, managing director/co-founder of Accuitive Medical Ventures. "Sadra expects to change this landscape significantly, providing physicians with the necessary technology to make PAVR a routine clinical procedure."
Placement is important, Martin said, because a device like this needs to function for the remainder of the patient's life so physicians "really don't like devices where they have to get it placed perfectly on their first try." He said interventional cardiologists are "very enthusiastic about something that gives them a second chance."
The investor enthusiasm reflects the enthusiasm of the doctors, Martin noted.
According to Sadra, the Lotus system allows interventional cardiologists to "easily navigate a technically-advanced prosthesis to the delivery site, and to precisely control its placement, without interruption to the patient's normal circulatory processes."
In addition to unique repositioning and self-centering features, the device has a proprietary delivery system that provides physicians with more control over the procedure, an early "leaflet" function during deployment that allows the valve to function immediately, and an ability to re-sheath and retrieve the prosthesis prior to final release, the company noted. Also, an adaptive seal minimizes leakage around the valve, Martin said.
Sadra's competition in this space includes Edwards Lifesciences and CoreValve (both Irvine, California). Edwards received a CE mark for its Sapien transcatheter aortic heart valve technology with RetroFlex transemoral delivery system in September 2007. CoreValve received the CE mark for its ReValving PAVR system a few months earlier, in May 2007.
According to Edwards, the Sapien valve is compressed onto a balloon-expandable stent to the approximate diameter of a pencil and threaded through the patient's circulatory system from the leg and expanded securely into place directly over the diseased aortic valve.
CoreValve says its ReValving system consists of a porcine pericardial tissue valve mounted in a self-expanding multi-level frame, which is permanently implanted over the diseased aortic heart valve by an 18 Fr-sized catheter. CoreValve notes that the small size of the delivery catheter is a key element of the system as it "greatly improves overall maneuverability and valve placement while also eliminating the need for surgical cut-down of the femoral artery."
"Aortic valve replacement is a $2 billion market," Larsen said. "By offering a solution that addresses the key needs doctors have identified as essential to make PAVR a standard therapy, and one which is less traumatic for the patient, the company has an excellent market opportunity."
Martin said Sadra has completed a feasibility study in Europe, which identified which elements of the system were working properly and which elements still needed further refinement. He said the $30 million capital will go towards finishing that development work, repeating the feasibility study and a CE trial. The company hopes to get a CE Mark for the Lotus system in 2011.
"We have had very successful European clinical experiences with our Lotus Valve System," Martin said. "We've confirmed through the physician and patient experience that we are firmly on the right track, and are designing even more improvements in functionality and user-friendliness as we move to bring the system to commercial viability."
In other financing activity:
• Metabolon (Research Triangle Park, North Carolina) said it has closed $5.3 million of an anticipated $11 million Series C funding round. This first portion closed on April 30, with the balance expected within the next 60 to 90 days, the company noted.
Metabolon offers global biochemical profiling (metabolomic) services to researchers working in drug safety and toxicology, bioprocess optimization, consumer products and other areas which benefit from insight into complex biochemical processes and how they change in response to experimental variables.
The company's technology has been used to identify biochemical biomarkers useful for the development of a wide range of diagnostics. These markers are being applied to the development of its own diagnostic tools for insulin resistance and prostate cancer, Metabolon said.
• Biotechnology firm Oragenics (Alachua, Florida) said it is seeking strategic alternatives to fund its continuing operations. These alternatives include, but are not limited to, raising capital through the sale of equity, the sale of specific business units, and the sale of the entire company. If its efforts are unsuccessful, Oragenics said it might be forced to discontinue operations and liquidate the company's assets.
"Our current financial condition coupled with the difficult economic climate has left us with a limited number of options to adequately fund the company such that we can continue operations," said David Hirsch, acting CEO/CFO. "While we remain optimistic that we will find an alternative that will allow us to continue to operate as a going concern, there can be no assurance that we will be able to do so."
Oragenics has a number of products in discovery, pre-clinical and clinical development, with a concentration in the main therapeutic area of infectious diseases, diagnostics, and oral health.