Posts Tagged stroke
Medical Device industry has been facing enormous and unprecedented challenges during the last several years. Only now it is emerging from the dark tunnel of funding dryout, layoffs, and lackluster job scenario. The 2014 Wilson Sonsini Medical Device Conference reflected some cautious optimism based on recent uptik in the industry. The challenges are not gone but companies have learned to work with the complexities. The conference this year focused on understanding the challenges still facing the Medtech startups and the new strategies that are emerging as response to these challenges. The conference was a sold out event with 600+ attendees that included CEOs, venture capitalists, investment bankers, market analysts, and industry strategists. Below are the highlights from one of the panels.
Funding Strategies for Entrepreneurs
Dried up funding continues to be a challenges for medtech start-ups. This panel was moderated by Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati. McGlynn said he is increasingly seeing companies getting funded, even PMA projects are getting funding. One of the strategies for PMA is to have a believable path to an existing market in Europe that will adopt the product. Building product is not the challenge, but for these, the regulatory approval process in the US, becomes a big hurdle. For bite size consumer facing, wearable type, or health IT projects, crowdsourcing could be a good strategy, said McGlynn.
The panelists included CEOs who shared their experiences in search for capital. The panelists also discussed how interests of the investors are changing.
Laura Dietch, President and CEO, BioTrace Medical, shared about the technology that emerged from the Stanford BioDesign program. BioTrace is developing a temporary cardiac pacing device to treat reversible symptomatic bradycardia, during general surgery for percutaneous valve procedures. This is a 510K device. BioTrace raised $3.5M from 5 investors. Dietch’s advice to the entrepreneurs? “You have to be tenacious, have good target partners, be willing to take a lot of rejections, be organized, and be creative. She also advised entrepreneurs to stay lean, whenever possible, have a physician on the team, and be clear from the beginning regarding the exit strategy.
Qool Therapeutics offers patented cooling technology to induce therapeutic hypothermia. This minimally invasive technology has applications in stroke, cardiac arrest, traumatic brain injury, sports injuries and so on. President and CEO, Beverly Huss shared how the company raised $1.5M from small investors that included COO at American Airlines, General Counsel at EBay, an executive at Dish Network and so on. She said these relationships were developed over the years. “Early stage investing is a labor of love and can come from people who believe in your ability to deliver on a technology they like”, said Huss. She also advised that entrepreneurs be relentless and follow every path and see where it takes them, and be open to learning the lessons from each path they pursue. What has changed is how we are bringing therapeutics devices to a consumer market, said Huss.
Dr. Daniel Burnett, President and CEO at TheraNova also talked about how the climate has changed. With his first company, they raised funding without any animal or human data; next company required huge clinical data and since then most companies need some human data, before money can be raised. TheraNova turned to corporations and also had 4 SBIR grants. Since 2006, Burnett raised or helped raise, over $95M for six venture-backed TheraNova spinouts, BAROnova, Novashunt, Velomedix, EMKinetics, Channel Medsystems, and Potrero Medical. For Channel MedSystems, he partnered with Mir Imran’s Venture Health Crowdsourcing platform. His advice to entrepreneurs was to be lean and mean and to focus on both cost saving and improved outcome. Burnett said he avoids PMAs. Angel investors have been beaten up badly and still recovering but he advised that entrepreneurs can go to crowdsourcing platforms like Venture Health or DealLabs.
Doug Wall, Managing Director, Volcano Capital talked about some of their portfolio companies. All in all, market for early stage investors is pretty lonely, said Wall. There was virtually no competition from 2009 to 2011 but that is now changing. There are some VC funds now taking an interest in early stage deals. Most successful companies are the ones that think outside the box. Answering the question regarding what would be more important market or people, Wall said, “we are flexible on market size, but most important thing to us is the management team, and then we look to see if the milestones are thoughtful, and if the team shares the strategy to be capital efficient”. He said, they avoid PMS entirely to mitigate the regulatory risk factors.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on April 14, 2014
Dr. Mark Borsody, Founder and Chief Medical Officer at Nervive Inc, spoke about stroke healthcare, at www.bio2devicegroup.org event.
Stroke has been a #1 cause of severe disability, #2 cause of death in the world (responsible for more than 5 million deaths, each year), and it is 4th leading cause of death in the US. About 800,000 people in the US have stroke, each year. One American dies from stroke, about every 4 minutes. In fact, stroke is responsible for putting the biggest healthcare burden, worldwide and the burden is likely to increase in the foreseeable future, said Dr. Borsody. Stroke results from “plumbing problem”, in the brain. Ischemic stroke is caused by blockage of a blood vessel due to reasons like thrombosis or arterial embolism. Hemorrhagic stroke is caused by bleeding of blood vessels of the brain, either directly into the brain or into the surrounding brain tissue.
While treatment options for hemorrhagic stroke are limited, current treatment options for ischemic stroke include intravenous “clot busting” through tissue plasminogen activator (tPA) or through endovascular catheter devices for blood clot retrieval. Worldwide, an estimated 180,000 tPA treatments are done every year and 22,000 clot retrieval treatments are done.
Honing in on the major problem, Dr. Borsody discussed why do so few patients with stroke receive timely treatment. Timely intervention is the key for treatment of stroke. Like all cells in the body, neurons and other brain cells require oxygen and glucose delivered through the blood in order to function and survive. A few minutes of oxygen deprivation can kill millions of neurons. Additionally, stroke can provoke inflammation, swelling (edema), and other processes that can continue the damage for hours or days after the initial attack. However, often treatment of stroke within 60 minutes is very rare due to the time required for patient transportation and in-hospital evaluation. Effective treatment for stroke can be simple, but it needs to be immediate. So how come there aren’t many innovations to bring the treatment to the patient, even to buy them some time?
Nervive’s Vital Flow Stimulator is a simple device that is aimed at targeting the facial nerve behind the middle ear. The objective is to control the cerebral arteries through the facial nerve, which regulates the function of the arteries. It is comprised of 3-4 cm coil placed over the ear. Magnetic fields readily penetrate any tissue and creates electrical currents in neural tissues, leading to axonal and soma depolarization. Early indications are that it is effective in treating ischemic stroke and it is safe in ischemic and hemorrhagic stroke. This device is moreover, simple enough to use without any special training. Vital Flow complements other therapies and bring exponential benefits of rapid treatments. The device will be inexpensive, portable, and extremely easy to transport in the ambulance. The treatment can be administered within a few minutes. Animal studies show increased blood flow after facial nerve stimulation and improvement in several measures after stroke.
Ending his talk, Dr. Borsody said, Nervive has a strong IP position, the technology is targeting a market with huge potential, and it is substantiated by preclinical and clinical science. They are starting fund raising for series A round. To emerge from the dark ages of stroke healthcare, we need some disruptive, out of box (out of hospital) thinking, said Dr Borsody.
Mark your calendars for following events……..
May, 6 – EPPIC will host Dr. Sarvajna Dwivedi, Founder, Pearl Therapeutics that was acquired by Astra Zeneca for $1.15B, last year. Register at http://www.eppicglobal.org, @EPPIC_GLOBAL
May 16, 17 – #TiEcon 2014 will feature Healthcare Track to showcase and discuss new innovative technologies in Life Science and healthcare industries, @TiEcon
May, 2014 – Healthcare Code-a-thon will be hosted by http://www.healthtechnologyforum.com @HealthTechForum
May 20, 2014 – “Pathways to Sustainable Health” conference hosted by http://www.healthtechnologyforum.com
You can follow me on Twitter at @DarshanaN
Every Tuesday exciting speaker – http://www.bio2devicegroup.org