bivacor Archives - Medical Design Sourcing

BiVacor raises $13M to support artificial heart trial

The BiVacor Total Artificial Heart (TAH) [Image courtesy of BiVacor]BiVacor announced today that it brought in $13 million from the Australian government to support its Total Artificial Heart program.

Australia’s Medical Research Future Fund (MRFF) provided a grant through its Artificial Heart Frontiers Program (AHFP). It aims to support the company’s TAH program and future product enhancements. BiVacor received FDA investigational device exemption to conduct a first-in-human study for the system in November.

The grant comes from a larger grant from MRFF to AHFP totaling approximately $32.9 million. The government wants the program to develop and commercialize devices to treat common forms of severe heart failure and bring new solutions to underserved patients.

BiVacor said the grant will support the clinical work on its TAH as it begins development to integrate wireless power sources. The company plans to begin its FDA IDE study in the first ha…

BiVacor picks former BioVentrix CEO for its corner office

New CEO Jim Dillon. [Image courtesy of BiVacor]Artificial heart maker BiVacor announced today that it appointed Jim Dillon as its new CEO and as a member of its board.

Dillon, an experienced medical device executive, most recently served as CEO of BioVentrix, a heart failure treatment developer. His appointment follows last week’s naming of Axonics CEO Raymond W. Cohen as board chair at BiVacor.

“Jim’s leadership style, combined with his experience in building high-performance teams as well as expertise in the heart failure field, makes him the ideal person to lead BiVACOR,” Cohen said in a news release. “We are thrilled to have him join as CEO.”

Dillon’s experience includes developing cardiovascular therapies to enable native heart recovery and reduce the size of myocardial infarction. It also extends to repairing adult and congenital cardiac defects and volume management for congestive heart failure patients.

Prior to his time at BioVen…

Artificial heart maker BiVacor names Axonics CEO as chair of its board

New BiVacor Chair Raymond W. Cohen. [Image from Axonics]BiVacor announced today that it appointed Axonics CEO Raymond W. Cohen as the new chair of its board of directors.

Cohen serves as CEO and as a member of the board at Axonics, which develops sacral neuromodulation technologies. He originally founded Axonics in 2013 and took the Irvine, California-based company public in October 2018. The long-time executive has more than 40 years of experience in the life sciences industry.

In addition to his roles at Axonics, Cohen serves as an independent director of SoniVie. The clinical-stage, venture-backed company develops denervation technology for uncontrolled hypertension.

Cohen now heads up the board at BiVacor, a company making a total artificial heart (BTAH). BiVacor received FDA investigational device exemption (IDE) for the artificial heart last month. It’s now set to conduct a first-in-human clinical feasibility study evaluating the use of the syst…

BiVacor wins FDA IDE for first-in-human artificial heart study

The BiVacor Total Artificial Heart (TAH) [Image courtesy of BiVacor]BiVacor announced today that the FDA granted investigational device exemption (IDE) for its total artificial heart (BTAH).

IDE approval allows BiVacor to begin its first-in-human early feasibility study (EFS) for the BTAH system. The Houston-based company aims to evaluate BTAH’s safety and feasibility as a bridge to a heart transplant for patients with biventricular heart failure.

BiVacor tapped 10 hospital locations for the study, for which it plans to initially enroll three patients. The company expects to begin the study in 2024 and to use its findings to lead into a subsequent pivotal study. This falls in line with the company’s timeline shared in March when it raised $18 million to support the BTAH’s development.

“I am eager to begin the BiVacor Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” said Dr. Josep…

Artificial heart developer BiVacor taps former Abiomed exec as CEO

BiVacor this week announced that former Abiomed executive Thomas Vassiliades was appointed CEO, effective immediately.

Prior to joining the company, Vassiliades was most recently the general manager of the surgery and heart failure business at Abiomed.

He has also served as the chief medical officer of the coronary and structural heart business of Medtronic, and as the chief medical officer and integration lead for Medtronic’s mechanical circulatory support effort in 2016. Vassiliades was a practicing cardiac surgeon for more than 18 years before joining the medical device industry.

“BiVacor led an extensive CEO search, and Tom was a clear choice given his experience, background, leadership style and exceptional track record,” BiVacor founder Daniel Timms said. “Tom has the skillset and credibility to guide BiVacor through its next chapter of transformation and advancement as we undertake the next stage of clinical activities leading up to first in…