Irvine-based Edwards Lifesciences Corp., maker of replacement heart valves and other cardiovascular devices, is working with the Oregon Health & Science University in Portland, Ore., on a technical training program.
The university’s Knight Cardiovascular Institute said that the Starr Educational Training Program provides Edwards engineers with in-person clinical experiences and a forum for cardiologists and engineers to discuss selecting patients, obstacles and approaches to procedures.
It intends to provide engineers developing advanced devices for treating heart disease “access and insights into various facets of clinical care, including ambulatory clinic, multi-disciplinary case conference, operating meeting, procedure implantation and post-procedure care” in the Knight Institute cardiovascular intensive care unit.
Edwards and Dr. Albert Starr, the institute’s executive chairman, have had a longtime collaborative relationship. Starr co-invented the world’s first artificial human heart valve in 1960 with engineer Lowell Edwards, a development that gave rise to Edwards Lifesciences.
“Through this educational collaboration with the [institute], Edwards is embarking for the first time on a structured program that enables our engineers who are developing further technologies to interact with clinicians providing care to heart patients,” said Stanton Rowe, Edwards’ chief scientific officer.
“More importantly, Edwards engineers can use a deeper appreciation of clinical and patient needs to create new designs to benefit patients.”
Mazzo Talks Customer Influence
A recent edition of industry website Med Device Online quoted James Mazzo, executive chairman and chief executive of Irvine-based eye startup AcuFocus Inc., on the subject of customers’ input in medical technology development.
Mazzo, speaking at a session of last year’s AdvaMed 2014 conference, recounted a conversation he had with executives at Mountain View-based Google Inc. about “taking a customer-oriented approach” to developing devices.
Google, which was looking for a partner to help develop and commercialize what it called a “smart contact lens” to measure glucose levels in tears, asked AcuFocus how long it had taken to develop a particular technology, Mazzo said.
The tech giant responded that it could develop the same product in two years, compared to the six years AcuFocus mentioned.
“The reason, I think, [Google could do] it in two was not that they were smarter,” Mazzo told attendees. He explained that it was because Google “actually involved the consumer … and understood the need of the consumer.
“They got rid of some of the stuff that we thought the practitioners would love. They averted that and went right to the consumer end of it,” said Mazzo, who’s also an operating partner in the Newport Beach office of venture capital firm Versant Ventures. “So I would tell you that I think people are starting to identify the consumer in the … process much earlier now.”
Drugmaker Responds to FDA
Mission Viejo-based Aeolus Pharmaceuticals Inc. said this month that it responded to a clinical hold placed by the Food and Drug Administration on an investigational new-drug application for its lead compound, AEOL 10150.
Aeolus is working with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority to develop AEOL 10150 to fight against exposure to radiation. The authority funds Aeolus’ development work under a five-year contract worth up to $118.4 million.
The FDA in September placed a clinical hold on Aeolus’ investigational new-drug application for testing AEOL 10150 in healthy human volunteers. The agency’s Division of Medical Imaging Products brought up several questions in its hold, including toxicology data and the potential for skin discoloration at the site of AEOL 10150 injections.
The drugmaker said it proposed to run several studies to address the FDA’s questions and that it has requested a meeting with the division to confirm that the action plan it submitted adequately addresses the agency’s questions.
CareTrust Buys Va. Community
San Clemente-based CareTrust REIT Inc. said this month that it bought an assisted-living facility in Christiansburg, Va., for $6.6 million.
English Meadows at Christiansburg has 39 units. CareTrust said the deal was a sale-leaseback with assisted-living operator Twenty/20 Management Inc. in Blacksburg, Va.
CareTrust also said it entered an agreement with a Twenty/20 affiliate to buy and lease back English Meadows Elks’ Home, a 169-unit independent- and assisted-living campus in Bedford, Va. Terms of that deal weren’t disclosed, but CareTrust said it expected a midyear closing.
The REIT was created in 2014 when Mission Viejo-based nursing home operator Ensign Group Inc. spun off its real estate holdings.
Bits & Pieces
Dana Point-based HemoLife Medical Inc. said it launched a medical device that detoxifies plasma in inflammatory conditions, such as severe sepsis or blood poisoning. The company said it’s shipping the device to Europe and Asia and will begin treating patients this month. … San Clemente-based Amada Senior Care said it launched websites to support its franchising partners and homecare clients.
