Aptus Endosystems has announced closing on US$25 million of equity financing. Synergy Life Science Partners, a new investor, led the round and was joined by existing investors US Venture Partners and Longitude Capital Management. Mudit K Jain, partner at Synergy Life Science Partners will join the company’s Board of Directors.
Proceeds from the financing will be used to expand commercialization of the HeliFX Aortic Securement System in the United States and Europe, where the company has already obtained FDA clearance and CE mark, respectively. In addition, Aptus will develop further HeliFX product offerings to fulfil unmet needs in the treatment of aortic aneurysms and thus increase the patient population who could benefit from HeliFX. The company also plans to execute a US clinical trial of the Fortevo AAA Endograft System in support of filing for premarket approval with the FDA. Lastly, Aptus will expand utilisation of the Fortevo system in key European centres, where it already possesses the CE mark.
“This commitment on the part of Synergy Life Sciences Partners and our current investors provides the company with necessary capital required to bring the HeliFX and Fortevo family of products to physicians treating patients with life threatening aortic aneurysms,” said James Reinstein, president and CEO of Aptus Endosystems. “We will judiciously utilise these funds to expand the use of HeliFX in targeted markets and introduce new aortic repair products, all while approaching profitability.”
“Aptus’ HeliFX and Fortevo technology platforms provide an innovative treatment option for millions of patients suffering from abdominal aortic aneurysm”, said Jain. “We believe that Aptus’ proprietary technology and world class management team uniquely position the company for significant growth in years ahead.” Alan Kaganov, partner at US Venture Partners and chairman of the Aptus Board added that “USVP is very encouraged by the accomplishments of the Aptus team. We welcome Synergy Life Science Partners to Aptus and collectively, we will continue to support the company’s endograft and fixation platforms to ensure that both patients and physicians have access to a new standard in long-term durability in EVAR.”
In its June 2012 newsletter, Aptus informed that its ANCHOR registry “is well underway and initial interest in the programme is exceeding expectations.” Sixteen clinical cases in Europe and the US have been enrolled and a number of study sites have received IRB and EC approval. “Physicians at six sites have completed both revision and primary cases and the registry group is pleased with progress to date.”
HeliFX Presentation at SVS
The company also reported that William Jordan gave a talk at SVS focusing on whether EndoAnchors (HeliFX System) will replace the Palmaz stent for treatment of problematic proximal aortic necks. The rate of type I and III endoleaks was zero at two years in STAPLE-2, US-IDE Clinical Study. Sac regression >5mm was 83.9% at 36-months. Jordan concluded that while both the Palmaz stent and EndoAnchors improve sealing, only EndoAnchors provide active fixation and therefore offer a potential advantage in patients with challenging proximal aortic necks.