Advanced Bifurcation Systems Inc. has a simple pitch for investors, cardiologists and people suffering from coronary artery disease who could be candidates for its developing stent product: simplicity.
The Newport Beach-based clinical-stage medical device maker’s main product is a bifurcation stent designed to improve the flow of blood through artery branches.
The stent is easier to implant and results in fewer complications and repeat procedures than other similar products that have gotten regulatory approvals, the company says.
There are plenty of potential candidates for the company’s coronary bifurcation product. It’s been estimated that up to 30% of all patients undergoing coronary surgery to open blocked arteries have a bifurcation lesion—disease in an artery’s main vessel and the side branch vessel.
Provisional stenting of the artery’s main branch is the current standard of care, but other device makers note that in many cases the side branch isn’t stented; that’s where Advanced Bifurcations’ products would come in.
2nd to Market
The company’s product would be the second of its kind to market.
Last year, Durham, N.C.-based Tryton Medical Inc. received Food and Drug Administration approval for the first dedicated bifurcation device, the Tryton Side Branch Stent.
Its device is a standard expandable single-wire balloon stent placed in the side branch artery, and a drug-releasing stent placed in the main vessel. About 12,000 people had been treated with the device early this year, the company reported.
Advanced Bifurcation’s device would be an improvement on cuurently available offerings due to simplicity, according to Chief Executive Charles Laverty. He joined the company as chief executive in April 2017.
“There is no direct comparison,” said Advanced Bifurcation Chief Medical Officer and co-founder Mehran Khorsandi, referring to the two companies’ products.
He said Advanced Bifurcation’s self-aligning stent is able to address a much bigger percentage of bifurcated lesions, “regardless of size, location or angulation.”
“We simplify the current 10 to 12 steps [for bifurcation] to four steps,” he said, adding that procedure time is “reduced anywhere from one and a half hours to three hours, down to 30 minutes.”
Laverty said the company is raising a $20 million Series A funding to support clinical trials. Previously, it had raised $7 million to support product development.
Tryton, by comparison, has raised more than $100 million, according to Crunchbase data.
Laverty said his company’s latest funding efforts target institutional investors. Proceeds will be used to expand research and development, including more engineers and technicians, and employees to handle regulatory work.
Advanced Bifurcation hopes to get European CE Mark approval for its product next year, followed by an FDA nod in 2020.
High-Risk
“One-third of all coronary artery disease requires bifurcation,” Khorsandi told the Business Journal last month at the annual Transcatheter Cardiovascular Therapeutics convention in San Diego. He said treating bifurcation blockage is “very complex, high-risk … with many variables,” which is why it’s mainly the purview of high-volume, expert operators.
Khorsandi is an interventional cardiologist and on the HARTS stent team at Cedars-Sinai Medical Center.
Coronary stenting is used during percutaneous coronary intervention, a nonsurgical procedure meant to improve blood flow to the heart by inserting a catheter tube into the coronary arteries.
Khorsandi said there were no dedicated bifurcated stents on the market until Tryton’s offering got FDA approval.
Dual System
The company’s technology platform is made possible by using a dual catheter system, eliminating the need for double-stenting.
It’s possible to achieve bifurcation without use of a true bifurcation stent, but Khorsandi said those methods aren’t preferred because placing a second stent increases the risk of the surgeon having to repeat the procedure to get the second stent in the right position. That also means recovery depends on the surgeon’s stenting technique.
“Restenosis remains an issue,” said Chief Technology Officer, president and co-founder Henry Bourang, referring to a gradual renarrowing of a coronary artery after a blockage has been treated with angioplasty and stenting, a complication that can lead to additional surgeries.
“Think about it, you go in with one wire, then in again with another wire, and then the balloons, all those exchanges and rubbing can cause irritation to the arterial wall,” Bourang said.
The company was founded in 2009; Khorsandi said he started working on the idea with Bourang a year earlier.
“Henry is the engineer. The two of us refined the idea together and did it literally in our kitchen,” he said.
Bourang has 29 years of senior management and technical experience in the medical device industry, including working for companies like Biosensors International Group, Edwards Lifesciences Corp. and Boston Scientific Corp.
Last month Advanced Bifurcation Systems added three patents in the U.S. and one in Europe. It currently has a portfolio of 40 patents.
Ready to Launch
The device maker beefed up its finance chops in December when Laverty named Ken Richards chief financial officer.
Richards previously served as chief executive and partner of the Toronto-based private equity firm he co-founded, York Bridge Capital. He also co-founded the Westlake/Santa Barbara chapter of Tech Coast Angels.
A month later, Advanced Bifurcation added Scott King as chief compliance officer.
