The biotechnology space is one that’s booming, with innovation seemingly around every corner. Nonetheless, even with all of the innovation taking place, there are still some conditions impacting millions of patients where physicians have little to nothing to offer in the way of relief. One such condition is known as Chronic Venous Insufficiency, or CVI. Although you may not know CVI by name, the condition afflicts 4.5 million sufferers in the U.S. alone. CVI’s symptoms include swelling in the lower leg, ankle, and feet, skin discoloration, and severe leg pain. Unfortunately, when a patient sees a doctor about CVI, the most common advice is to lay down with the legs elevated or try compression stockings, neither of which are likely to provide relief to the patient nor treat the the underlying condition. However, if Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI) has their way, a more effective approach to CVI could be on the way.
HJLI May Provide The Answer 4.5 Million Patients Per Year Have Been Waiting On
If you’re like approximately 40% of adults in the U.S., you’re no stranger to varicose veins including discoloration and lower leg pain. In the more severe cases of CVI, blood pools in the lower extremities causing swelling in the lower leg, feet, and ankles and causing intense pain. If you’ve ever had a Charlie horse in your leg, you can imagine the pain caused by more severe cases of CVI. That’s precisely the pain that Hancock Jaffe Laboratories is working to relieve.
A human leg contains valves that assist in getting blood for the lower leg back to the heart. When those valves begin to fail, gravity takers over, and blood pools in the lower extremities. As a result, the patient will generally experience swelling in the lower leg accompanied by severe and debilitating pain. The condition is also known to cause sores on the skin of the lower leg that can become infected. Severe CVI results in over 700,000 hospitalizations each year in the U.S. The condition frustrates both doctors and patients as there are currently no effective treatments available and no cure.
While little innovation has taken place surrounding CVI, HJLI is quickly changing that. The company’s flagship product, and what I find to be the largest value proposition, is known as VenoValve®. So, what is VenoValve? It is a bioprosthetic valve made from porcine tissue and with a stainless steel frame, being developed to combat the effects of and possibly cure CVI.
The VenoValve is designed to be surgically implanted in the deep vein system of the leg, relieving venous pressure caused by malfunctioning valves. Once proper valve function is restored, blood is able to flow back to the heart, reducing or eliminating the effects of CVI.
Clinical Testing Is Just Around The Corner
Hancock Jaffe is finishing its pre-clinical testing of the VenoValve, and the first in-human testing is only months away. That study, scheduled to take place in fall of 2018, will include between 5 and 10 patients with severe CVI. In addition to immediate results, HJLI will track 30-day, 60-day, and 90-day results and will follow patients for a 6 month period. After compiling 6 months of data, the company plans to apply to the U.S. Food and Drug Administration (“FDA”) for an Investigational Device Exemption (IDE) application in order to conduct a larger, pivotal trial. That study will include approximately 50 patients at sites throughout the U.S. and is expected to be the last study needed before seeking FDA approval for the product.
Breaking Down The Massive Opportunity That Is Venous Valve
In addition to providing relief to patients suffering from severe CVI, the VenoValve represents an enormous economic opportunity for Hancock Jaffe and its shareholders. The company estimates the U.S. market for the VenoValve to be approximately $50 Billion and Europe and Asia also represent very large potential markets. With no current effective treatments available for severe CVI, the VenoValve would be the first product in the market to effectively treat and potentially cure CVI.
New To The NASDAQ But Not To Medical Devices
HJLI just hit the market with their IPO on (date will be filled in post IPO). However, the company is no stranger to developing innovative medical devices. In fact, the company was founded by two pioneers in cardiovascular care Warren Hancock and Norman Jaffe.
Norman Jaffe, Ph.D. – Dr. Norman Jaffe was a leading specialist in the design, development, and manufacturing of biological heart valves, vascular bioprosthetic devices and orthopedic biological devices. ProCol® Vascular Bioprosthesis, and various other key breakthroughs in cardiovascular medicine.
Warren Hancock – Warren Hancock is also a key figure in the world of cardiovascular medicine. In fact, he was the inventor of the HancockTM II valve. The valve, first introduced in the 1980s, has stood the test of time and is still being commercialized to this day by Medtronic PLC (NYSE: MDT).
While the VenoValve is the flagship product candidate at HJLI, it is only one of three products currently being developed by the company. The other two products include:
Pediatric Bioprosthetic Heart Valve – HJLI is also working on a bioprosthetic heart valve that would be ideal for the pediatric market. This heart valve, which provides output equivalent to a heart valve that is 2 to 3 sizes larger, may reduce or eliminate the need for subsequent valve replacement surgeries which is the current standard of care and children grow and adopt a more active lifestyle. There are approximately 50,000 pediatric valve replacement surgeries in the U.S. each year.
CoreoGraft® – Hancock Jaffe’s third product, called CoreoGraft, is a coronary artery bypass graft to be used during coronary bypass surgery, potentially eliminating the need to harvest a vein from the patient’s leg or arm. Vein harvesting is an invasive process that is painful, and subject to complications.
The Opportunity Is In The Making
The bottom line here is that Hancock Jaffe Laboratories represents what could become an incredible opportunity for all involved. With multiple products that address massive untapped markets and strong pre-clinical data providing validity to the company’s efforts, this company is a hard one to ignore!
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