Irvine-based medical device maker Hancock Jaffe Laboratories Inc. (Nasdaq: HJLI) entered a sponsored research agreement for the development of its CoreoGraft product with Houston-based Texas Heart Institute, one of the largest cardiovascular centers in the U.S.
The company’s CoreoGraft implant is designed to be used for coronary bypass procedures, the surgery that creates a new pathway to improve blood flow to the heart.
Saphenous vein grafts—using veins from a patient’s legs—have been broadly accepted as the biomaterial in coronary artery bypass procedures.
Hancock Jaffe’s product is a potential alternative to that type of graft. Its CoreoGraft device would eliminate the need for vein and artery harvesting procedures, and any resulting complications from those procedures, the company says.
The company notes that studies have shown 40% of saphenous vein grafts closed or are clogged as early as one year after surgery.
There are currently no Food and Drug Administration-approved grafts for the Hancock type of product.
“I am personally interested in the CoreoGraft because I recognize the potential and unmet clinical need for an alternative to saphenous vein harvesting, which could positively impact the lives of so many people suffering from heart disease globally,” said Dr. Luis Sampaio, co-director of the cardiovascular research laboratories at Texas Heart.
Hancock Jaffe estimates 150,000 coronary artery bypass surgeries are performed in the U.S. each year and that approximately 300,000 to 450,000 bypass grafts are used.
The company, which went public this year, has a market value of about $30 million.
Clinical
Newport Beach-based ImmunogenX, along with Mayo Clinic, announced the completion of a longitudinal study to further evaluate the use of its diagnostic test, CypCel, for recovering celiac disease patients.
Celiac disease is an autoimmune disorder of the small intestine that results in gluten intolerance.
CypCel uses a cholesterol-reducing serum to measure the health of the small intestine.
ImmunogenX Chief Scientific Officer and co-founder Jennifer Voyksner said the company is excited to “develop this new diagnostic method, which serves as an alternative to an expensive and invasive biopsy.”
The company also develops a drug that aims to break down gluten proteins into “small physiologically irrelevant fragments.” The drug candidate has completed two second-phase trials.
FDA
• ICU Medical Inc. (Nasdaq: ICUI) received FDA clearance for the Diana ChemLock Transfer Set this month.
The single-use system is used to transfer a drug vial to an IV bag, and “can be used for hazardous drug preparation to prohibit the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system,” according to a company statement.
The device is part of the Diana compounding workflow system, which the company launched in 2016.
The San Clemente-based device maker is a pure-play infusion therapy company.
It has a $5.3 billion market cap as of press time and ranks No. 1 among OC’s large public companies by sales growth (see story, page 5).
• Endologix Inc. (Nasdaq: ELGX), the Irvine-based medical device maker that treats aortic disorders, said the FDA classified its July voluntary recall of AFX Endovascular AAA system as Class I.
It’s the most serious classification of recall, which is issued when there’s reasonable probability that the product could cause serious adverse health consequences or death.
Endologix shares dropped about 77% from a 52-week high of $6.63 in July and currently trade around $1.50 for a $138 million market cap.
The stent graft is designed to treat abdominal aortic aneurysm—an enlargement or outward ballooning of that part of the artery that can lead to tear or leakage within the wall of the blood vessel.
The device maker said it’s recalling the product due to continued reports of Type III endoleaks, situations where blood continues to flow in the aneurysm, thereby increasing the risk of a rupture.
Endologix said most endoleak reports have to do with a graft material that the company has not manufactured since July 2014, according to company filings.
Chief Executive John Onopchenko, who was promoted to the role a year ago from chief operating officer, has made quality control a priority since taking over the top spot at the company.
The company appointed Jeff Fecho as chief quality officer in June.
