Device For Monitoring Brain Injuries
Syncatch is a med-tech company. It’s created a solution to change the way traumatic brain injuries are monitored and treated.
The company’s solution gives physicians and critical care teams the ability to know, with a high degree of specificity, whether a patient is at immediate risk and requires brain surgery.
In the same way that cardiac catheterization can diagnose and treat coronary artery disease for patients, this solution can diagnose and treat the injured brain.
(Please note: This particular startup is raising funds from accredited investors only. An accredited investor is someone with a net worth of at least $1 million, or annual income of at least $200,000, or $300,000 with their spouse.)
One of the most feared, and common, effects of damage to the brain is “cerebral edema,” or the swelling of brain cells. This is considered among the most dire and time-sensitive medical emergencies.
When brain cells swell, this constricts fluid pathways, leading to fluid accumulation. This increases pressure in the brain, reduces blood flow, and causes irreversible damage to brain tissue. Often, it results in disability or death.
More than 65 million people worldwide suffer head trauma in an accident or significant bleeding following a hemorrhagic stroke.
For these people, current methods of monitoring intracranial pressure and providing therapy are insufficient, inaccurate, and outdated. For example:
• Intracranial pressure monitors are necessary, but insufficient.
• External ventricular drains (EVDs) are commonly used to extract fluid, but have a limited effect on the patient.
• And decompressive craniectomy, an operation in which part of the skull is removed to give a swelling brain room to expand, is a high-risk procedure.
With a need to develop better solutions, notable companies like GE, Philips, Edwards, and Medtronic have all become what Syncath calls “active players” in the neuro-monitoring and neuro-intensive care spaces.
Meanwhile, M&A activity for med-tech companies focused on critical care monitoring has been strong. For example:
In 2012, Oridion, a respiratory monitoring company, was acquired by Covidien, a medical device company, for $346 million. Oridion’s revenues at the time were $64 million, translating to an estimated 5.4x “P/S” multiple (this is a measurement of a company’s acquisition price as compared to its annual sales).
And TandemLife, a company creating a cardiac assistance device, was acquired by LivaNova (Nasdaq: LIVN), for $250 million in April 2018. At the time, LivaNova had estimated annual revenues of just $9 million, equating to a 27x P/S multiple.
With respect to Syncath, its solution is unlike anything that’s on the market. While the current standard of care only monitors pressure levels in the brain, the company’s solution monitors cerebral blood flow (CBF) and brain elastance. According to Syncatch, its device “transforms a single dimensional outlook into a three-dimensional assessment.”
Brain elastance is a measure of the pressure changes due to a known change in volume. The value of elasticity tells the neurosurgeon at any moment whether the patient needs surgery or whether they should be left alone to stabilize and recover.
Syncath’s solution is a pulsating balloon and intracranial pressure sensor (ICP) that’s integrated with a commonly used disposable EVD. The device is placed into the brain like an EVD and controlled by the Syncath console.
This device is identically sized and inserted in the same manner as current monitoring probes and drains, meaning physicians won’t need to learn a new procedural technique.
To estimate the amount of cerebral blood flow (CBF), the pressure response to a volume change created by the balloon is entered into an algorithm based on a model to track CBF levels.
By pressing a button, the system can switch from a monitor to a therapeutic device. Specifically, the EVD has a balloon that inflates and deflates in synchrony with the heart cycle to help pump blood through the brain. When inflated, the balloon will squeeze blood out of the brain and, when deflated, it creates a suction action to increase blood flow.
Syncatch is in the process of completing its R&D phase, including verification and validation of its elastance and CBF monitors.
The company completed two successful experiments of its device that showed reduced intracranial pressure, increased cerebral blood flow (by 25% to 35%), and improved brain oxygenation (a 25% increase).
With funds raised, Syncatch will aim to enter and complete its First in Human clinical trials by Q4 2020. It will then file submissions with the FDA to receive clearance for its device.
Alon is a serial entrepreneur who has worked for several medical-related companies.
He founded BrainsGate, a medical device company developing treatments for patients suffering from diseases of the Central Nervous System.
He then served as CEO of Nicast, a company developing implantable medical devices made from electrospun polymer nanofabrics.
Notably, Alon founded Endospan, a medical device company creating stents for patients suffering from cardiac-related illnesses. He spent nine years with the company, serving as CEO and a board member.
He earned a Bachelor’s and Master’s degree in Electrical Engineering from Tel Aviv University.
Ofer has 25 years of experience in product management and the medical device industry.
Initially, he was Medical Director for Rimed, a company developing a transcranial doppler device used to measure blood flow in brain blood vessels.
He then held the same position with SuperDimension, a company focused on electromagnetic intra-body navigation technology.
For two years, he was Medical Director for Cardiosonix, a company developing devices intended for measuring cerebral blood flow, and then spent a year as the company’s Director of Clinical Research.
Ofer spent nine years as Founder & Chief Technology Officer of Neetour Medical, a startup creating non-invasive CO2 measurement devices for respiratory monitoring.
He earned an MD from Tel Aviv University.
Ofer has 30 years of experience in the medical device industry.
Prior to starting Syncath, he was a professor of Biomedical Engineering at Tel Aviv University, and later spent time as Chairman of the Department at the university.
He earned a Bachelor’s degree in Electrical and Electronics Engineering from Tel Aviv University and a Ph.D. in Biomedical Engineering from Drexel University.
Omer began his career in the Israeli Air Force. During that time, he was a flight surgeon and airborne doctor.
From there, he spent five years as a neurosurgery resident at Rambam Health Care Campus in Israel, before studying for his Ph.D. in Biomedical Engineering at Tel Aviv University.
He also obtained his MD from The Hebrew University.
Shimon previously worked for Idanit, a technology company that’s now part of Hewlett-Packard (NYSE: HPQ).
He earned an MBA from The Hebrew University of Jerusalem.
Before working for Syncath, Or was a mechanical engineer at Endospan, the medical device company founded by Alon.
Throughout his career, Or has experience developing medical devices, specifically implantable cardiovascular products.