Category Archive For "Startup Spotlight"
Endoscopic procedures have a problem. The technology used in them hasn’t changed much since it was introduced in the 1970s. Arthroscopy is a particularly troubling area for old technology. With over 2 million procedures performed each year, it stands to reason that the tools to perform it would have gotten significantly better. Indago an Ohio-based company with CEO Eugene Malinskiy at the helm. Its first product, ArthroFree, is a wireless camera for minimally-invasive procedures that aims to change the world of endoscopy.
What is ArthroFree?
Aimed directly at arthroscopy, ArthroFree is the first product from Indago’s platform. The company states that it will have drop-in compatability with existing surgical suites, which will lower the barrier to adoption. There are a number of advantages that ArthroFree holds over the status quo, not the least of which is removing the potential fire dangers associated with existing arthroscopy systems.
Beyond the safety aspect, ArthroFree also eliminates the need for wires in the arthroscopy procedure. This helps to reduce setup and teardown time, and removes a significant amount of sterilization work that goes into today’s procedures. As anyone who has worked in a hospital knows, removing sterilization work holds the potential to reduce hospital-acquired infections, leading to better end results for the patient and the provider.
The Indago Team
Don’t be fooled by the headshots of a young team. CEO Eugene Malinskiy started his first company at 14 years old, and sold it after running it for 12 years. He followed that by opening DragonID, a biomedical engineering company whose success landed Malinskiy on the Forbes 30 Under 30 list for manufacturing. The company remains both small and lean; traits that Malinskiy appears to be rolling over into Indago as well.
Cofounders Daniel Dudley and Ilya Malinskiy bring their engineering chops to the team, having held lead roles at companies ranging from startups to the Fortune 500. The team also has a strong advisory board, adding to the pool of knowledge from which Indago is able to pull.
The seemingly endless opioid crisis in the United States has been the subject of news stories, regulation, lawsuits, and too many deaths to count. A quick search across the AngelMD network shows companies addressing the problem from just about every direction, but Neumentum has found a niche that other companies have failed to address.
The Opioid Problem
According to the National Institute on Drug Abuse, more than 115 people die each day after overdosing on opioids. While not all of these cases can be traced back to a genesis of a prescription, any number greater than zero should be considered too many.
As anyone who has done their research can tell you, there are many facets of fault when it comes to the problem. Not the least of which being the introduction of pain as a vital sign. Physicians need to be able to treat pain, but without the potentially harmful addiction and side effects that come with opioids. Nearly 29 percent of all patients who are prescribed opioids misuse them, and as many as 12 percent develop an opioid addiction. This frequently leads to heroin use once the legal supply runs out.
The Neumentum Solution
Neumentum’s lead product is ketorolac. If that generic drug name sounds familiar to you, it probably should. Toradol is the most-recognized brand name for ketorolac tromethamine, a powerful nonsteroidal anti-inflammatory drug (NSAID) that is used for management of acute, severe pain. The problem with Toradol is that it is alcohol-based, and so it cannot be used in a continuous dose. Neumentum has developed a reformulated version of ketorolac that is non-alcoholic and suitable for continuous 24-hour infusion.
Ketorolac was dosed more than 45 million times in the United States in 2017. Its popularity continues to increase as hospitals look for ways to avoid opioids in post-operative settings. However, the current formulation of ketorolac with an alcohol base means that it is only suitable for bolus injections. This leaves periods of untreated pain, and has associated discomfort for the patient. The alcohol base also The Neumentum formulation has no associated pain, and can be delivered via continuous IV drip, leading to a significant reduction in dosage for a similar effect.
The Neumentum Story
The team has worldwide rights to five novel, non-opioid pain products. The new formulation of ketorolac is held under patent until 2036, and the company is aiming to enroll patients into phase 3 of clinical trials in Q4 of 2018.
Spinal fusion surgery is a common neurosurgical procedure to eliminate painful, abnormal motion between bones in the spine. Over 1.3 million surgeries are completed each year, with over 500,000 in the United States alone. Sadly, nearly 40 percent of spinal fusion procedures fail, requiring painful follow-up procedures that decrease the patient’s quality of life. By including a smart, wirelessly-controlled monitoring system within traditional spinal fusion implants, Intelligent Implants has shown not only greater surgical success, but also the ability to monitor the progress of the fusion in real time.
SmartFuse – Induce, Direct, Monitor
Traditional spinal fusion surgery requires screws to be implanted into the spine, and a cage to be inserted between the vertebrae that the surgeon wants to fuse. When bone growth occurs over the cage, it can often times creep into the spinal column as well. SmartFuse uses an electric field within the spinal canal that can help to eliminate this bone growth, leading to reduced need for subsequent procedures.
The need for routine, post-operative imaging is also dramatically reduced. Since SmartFuse can monitor bone growth in real-time, the surgeon is able to watch as the ossification occurs, and see if the bone is growing into areas where it shouldn’t. By adjusting the current density in different regions, the surgeon can then direct the bone growth, ensuring that it solidifies where needed.
X-ray and CT scans are the normal methods for monitoring progress after a spinal fusion surgery. These procedures are expensive, time-consuming, and often not timely enough to catch a problem before it happens. This real-time monitoring function of the SmartFuse system allows for rapid adjustments of stimulation settings without the need for scheduled imaging.
The Intelligent Implants Results
Intelligent Implants shows a decrease in non-unions of up to 75 percent versus standard implants. Better still, because of the controllable system, fusion rates are much faster than “dumb” implants allow. Patients are able to track their progress, while avoiding expensive CT or MRI costs. Payers have access to compliance data, and physicians get support for their decisions while also monitoring compliance and adjusting the SmartFuse system as needed.
The company was named as a winner in the J&J Quickfire Challenge, and a graduate of the JLABS incubator.
The backbone of non-emergent central venous access, the ubiquitous PICC line (peripherally inserted central catheter) has become an integral patient care tool since its advent in the 1970s. In comparison to other central venous access options such as tunneled chest catheters and ports, the PICC line can be placed relatively inexpensively by an intravenous access nurse with less patient discomfort and lower risk of certain immediate complications such as pneumothorax.
Benefits vs. Complications
However, balancing these benefits are significant potential complications arising from the placement of a long catheter into a small caliber peripheral vein with multi-week indwell time. These complications include thrombosis, commonly of the peripheral vein but not infrequently of the deep central veins (deep vein thrombosis or DVT), sometimes even resulting in clinically significant pulmonary embolism (PE). Resulting catheter dysfunction typically requires secondary interventions to maintain access such as thrombolytic therapy administration or device exchange.
Catheter related bloodstream infection is another potential complication which significantly increases morbidity, hospital stay and overall cost of care. These adverse events are considered avoidable and therefore not reimbursed by payers.
As a vascular and interventional radiologist, the clinical conditions of PICC line dysfunction are well known to me, as it is my service that is tasked with fixing the problems that arise. While a majority of these lines are placed bedside, the number of difficult placements that require MD intervention is increasing at a rapid rate.
Contributing to this change is a combination of factors including an older and sicker patient population who have had a multitude of venipunctures and line placements in the past leaving the venous pathways constricted or obstructed with fibrosis. Also, a greater number of patients are living longer with malignancies and other hypercoagulable states and often present with device related acute DVT/PE, requiring systemic anticoagulation and sometimes catheter directed thrombolytic therapy.
Past improvements in device design, such as antithrombotic coatings and additives, are inelegant solutions that merely mask the underlying problem caused by a thrombogenic intravenous foreign body. As a result, these methods have only marginally mitigated the complications.
Access Vascular – A Better PICC
Access Vascular has developed an advanced bulk hydrophilic biomaterial that is strong, flexible, and biocompatible. The material has a high water content and a neutral surface charge, yet is strong and load-bearing. These features make it the ideal material from which to craft long-term implantable vascular access devices in order to markedly reduce thrombosis, and in turn, almost completely eliminate complications and adverse events seen with current devices.
The proprietary biomaterial is not recognized by the body as foreign, and therefore does not trigger the body’s thrombotic response. Without adherent blood products on the catheter to act as an origin site for infection as well as the inability for microbial biofilm to grow across the hydrophilic surface, the device has the potential to significantly lower infectious complication rates without relying on antimicrobial coatings or additives.
In studies, the biomaterial has proven to be antithrombogenic. It has shown up to a 98% reduction in thrombus accumulation in comparison to controls. The company is now conducting longer-term preclinical studies that feature up to and greater than 30 days of indwell time. The testing thus far has demonstrated the potential for superior clinical outcomes and lower healthcare costs compared with existing technologies.
The HydroPICC is predicted to decrease morbidity, shorten hospital stays, advance treatment, and improve the patient experience all while reducing costs. While the HydroPICC will be the company’s first offering, they are in early stage development of hemodialysis access as well as implantable port devices. The aggregate venous access market is ripe for innovation as the current market leading products are less than ideal in their rate of thrombogenic and infectious complications. The combined market in the US is approximately $1.2B annually, and $3.5B worldwide.
One factor that makes the heart such an amazing muscle is how precisely every part of it must work together to perform its job. A simple leaky valve — known as aortic insufficiency (AI) — can lead to a complicated and difficult valve replacement that often requires repeat treatment and special medication for the life of the patient. BioStable Science & Engineering, an Austin-based company, has developed an alternative treatment device that reinforces the natural ring around the heart valve. This annuloplasty device simplifies and standardizes the procedure and solves the complex anatomy problems of the aortic valve.
Aortic Insufficiency in the World
Over 2.5 million people suffer from AI. A quarter of those undergo surgery each year to treat the problem. The current options are either replacement or repair. The outcomes of these surgeries are largely positive, but they have lifelong negative impact. For instance, biologic valves require a subsequent operation in as little as 10 years, while mechanical valves require a lifetime of anticoagulation medication.
The underlying issue with valve surgery goes back to an earlier point related to the precision and complexity of the heart muscle. The ring of the valve, known as the annulus, needs to be an exact shape. If it’s distorted in any way, it can allow for aortic insufficiency. While annuloplasty (the surgery required to repair the annulus) is not an entirely new technology, it’s complicated by the exacting needs of the heart.
The BioStable Science Solution
BioStable Science & Engineering has two products in its portfolio that directly answer the problems related to aortic annuloplasty. The HAART 300 device is designed for patients with normal (trileaflet) aortic valves, while the HAART 200 device treats the congenital heart defect of bicuspid valves. Both devices are implanted with sutures, using proven and familiar principles of previously-successful valve repair procedures.
The end result is a faster, simpler, and more standardized technique that is applicable to every type of aortic insufficiency. Compared to valve replacement surery, patients see more positive outcomes and improved quality of life.
The Journey Thus Far
BioStable Science & Engineering is in the commercial stage, with the HAART 300 device being implemented into 16 centers across seven European countries. The FDA has cleared the HAART 200 and 300 devices for use in the United States, with the products seeing use in seventeen heart centers across the country.
The company is presently seeking an additional $2 million to its Series B round, with the intent to seek a strategic exit from existing interested parties. Alternately, as the company is already producing significant revenue ($735,000 to date), the additional money could be used to provide the resources needed for a near-term cash positive position.