Posts Tagged stroke

WSGR 2014 Medical Device Conference – Funding Strategies for Early Entrepreneurs


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.  image003

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.

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Rapid Non-Invasive Treatment for Stroke


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.

Microphotograph of HE stained section of human...

Microphotograph of HE stained section of human brain tissue upon acute ischemic stroke. Orgininal magnification 400x (Photo credit: Wikipedia)

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.
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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

 

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Intravascular Magellan Robotics Catheter System by Hansen Medical


Francis Macnamara, VP of Advanced Technology at Hansen Medical, talked about their proprietary intravascular robotic catheter system at www.bio2devicegroup.org event.

Hansen Medical was found in 2002, as an alternate to Intuitive Surgical’s robotic surgical tools.  Intuitive’s tools are rigid tools that require incision closer to the organ, said Macnamara.  A flexible device can go in through the femoral artery and can get a flexible catheter inside, with the control of the robots.  Sensei system was Hansen Medical’s first electrophysiology based robotic navigation system that offered catheter stability with force sensing, with a potential for reduced fluoro for physicians, and instinctive 3D control at the tip. Sensei systems mapped out the heart, prior to doing the ablation.  Hansen Medical has now unveiled a new catheter system, the Magellan Robotics Catheter System.

But first, how big is the EP market and what is the prevalence of AF or atrial fibrillation?  About 3.1 M Americans suffer from AF.  Atrial fibrillation is the most common arrhythmia in elderly persons and it creates a huge potential risk for stroke.  In 2012, the US, market for cardiac rhythm management (CRM), electrophysiology, and ablation devices, was valued at $6.8 billion.  Worldwide, over 13,000 AF procedures are done annually, said Macnamara.  Over 1150 AF patients are treated in EC/IRB approved clinical studies.  These procedures lead to 100% success in delivering therapeutic modality.

Open surgeries are going down across the world and most procedures are now increasingly minimally invasive procedures.  However, like interventional surgeons, the vascular surgeons often lack the skills for doing minimally invasive surgeries.  Surgeons would be more effective with robotic procedures specifically around complex regions of the anatomy, like the aortic arch, common carotids etc.   By pushing the catheters in these complex anatomical regions, these procedures can lead to major complications.  With robotically steering the catheters, these complications can be avoided, said Macnamara.  Additionally, with greater control at the tip, surgeons can make controlled lesions and stable sheath helps with the placement.   With robotic procedures, the surgeons can also have more predictability and certainly with regards to time.  Since surgeons have to be prepared for complications that can turn non robotic surgeries into open procedures, they have to block extra period of time.  With robotic surgeries, they can adhere to the time schedule and thus it would enhance their efficiency.

Hansen Medical recently unveiled its new Magellan Robotic System that cannulates peripheral vessels and delivers simultaneous distal tip control of a catheter and a sheath from a centralized, remote workstation.  Macnamara showed videos that indicate that this system gives the physician a right balance of flexibility with precision and control.  Early adoption in Europe indicates great success in procedures like PAD, Splenic Aneurysm, Abdominal Aortic Aneurysms and so on.  Clinical data suggests that with this system there is less vessel wall trauma to the patients, while the physicians experience greater success with higher efficiency.  The next gen system will give independent control of both bends as research indicates that double bend will deliver huge benefits.  Hansen Medicals’s technology is very exciting and we will stay tuned.  The talk ended with highly interactive Q&A session.  Magellan Robotic System

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