Jeffrey Yeung, Hansen Yuan and Satyajit Marawar, founders of Aleeva Medical
Jeffrey Yeung, Hansen Yuan and Satyajit Marawar make up one of the teams that will move on to the next round of judging in the M2D2 contest. Their company, Aleeva Medical, was chosen from the pool of applicants because of its true potential to disrupt medicine.
What is Aleeva Medical all about? The innovators describe their company in a MedTech Boston Q&A:
1. Briefly describe your technology.
Contrary to common perception, only 1-3% back patients with excruciating pain have herniated discs. Approximately 85% of back pain patients show no nerve impingement. However, nearly all have at least one black disc from degenerative disc disease under MRI.
Intervertebral discs contain no blood vessels. Oxygen and nutrients are diffused through capillaries in endplates into the disc to feed disc cells. During teen-age years, formation of calcium layers begins to fortify the endplates, blocking and occluding many capillaries from supplying oxygen and nutrients into the disc. Diffusion of oxygen and nutrients becomes shallow. Cells in the mid-layer of the disc nucleus experience chronic hypoxia and starvation. Disc cells can live without oxygen, but die without sugars. Sugars responsible for water-absorption in proteoglycans of the nucleus are released to feed disc cells, but anaerobic metabolism of sugars produces lactic acid within the disc. Acid erodes the disc to form fissures, leaking lactic acid into surrounding tissue. Persistent acid burn leads to chronic inflammation and disc pain. In addition, depletion of sugars in proteoglycans desiccates the disc, turning white discs black under MRI.
Discography is used to diagnose disc pain. Spinal needles are fluoroscopically guided to inject X-ray contrast into black discs to flush lactic acid through fissures onto inflamed tissues and cause instant excruciating pain. Continuous degradation of proteoglycans leads to a hollow and desiccated nucleus. As a result, the disc is flattened, and compressive load is transferred from disc to facet joints, causing strain, facet erosion and pain.
Disc degeneration and back pain is a blood-plasma transport problem within the disc. Braided nylon suture is used as the Disc Hydration Filament (DHF), which has capillary action drawing whole blood 10 cm against gravity, and holding blood plasma as a sponge. Spirals of DHF are micro-invasively implanted through a patented delivery device into the nucleus of painful discs to draw blood plasma from diffusion zones of endplates into the acidic mid-layer of the nucleus. Bicarbonate in blood plasma neutralizes lactic acid; nutrients feed cells; water rehydrates the desiccated disc. The DHF spirals fortify the hollow disc as a filler to reduce facet load and pain.
2. How does it add value to a clinical environment?
Pain relief was nearly instant when DHF were delivered into the nuclei of 9 patients in a pilot clinical study. Within a week, average pain was reduced 63%, disability reduced 76%, and further improvements continued during follow-ups. MRI of the black discs turned from black to grey within 6-12 months, indicating rehydration of the desiccated disc and potential to halt progressive disc degeneration and avoid surgery.
DHF may also treat recurrent pain from rapid disc degeneration adjacent to spinal fusion in approximately 650,000 procedures per year in US. In addition, many fusions are done without discectomy, resulting in persistent irritation of chronic inflammation by the lactic acid leaking from discs between fused vertebral bodies.
3. How is it disruptive?
For most back pain patients, surgical intervention is premature, and pain management is temporary. DHF aims at the unmet need of 70-80% back pain market due to early disc degeneration, while 95% spinal devices and surgical procedures aim at crowded late-stage spinal defects. Furthermore, DHF may halt progressive disc degeneration by rehydrating and feeding the disc to prevent further deterioration from reaching spinal instability, stenosis or surgical necessity.
Intradiscal ozone injection, plasma coblation and IDET have inconsistent or inconclusive data for disc pain, probably due to indirect reduction of lactic acid. Destructive power of these therapeutic devices can (1) kill or disable disc cells to reduce production of lactic acid, or (2) cauterize the capillary at the endplates to further desiccate the degenerating disc. As a result, acid leakage through fissures may decrease, but facet loading, spinal instability and stenosis are accelerated.
In contrast, DHF is a constructive device, bridging and expanding diffusion zones throughout the intervertebral disc to neutralize lactic acid in the mid-layer of the nucleus. Disc cells are fed with the possibility of producing water-retaining proteoglycans to reduce facet-loading pain and prevent spinal instability and stenosis.
4. What is your target market?
Chronic back pain has been the most burdensome disease afflicting 2-8% global population. Spine surgery is risky particularly for nearly 85% patients with early degenerative disc disease. Initial indication of the DHF is disc pain from lactic acid burn which afflicts 39-42% patients. Approximately 88 M disc pain patients are in patented countries of 4.3 B people. Assuming 1% penetration, only one level treatment per patient and $2K/DHF, gross revenue is approximately $1.8 B per year with 95% margin. Additional evidence is needed to show disc bulking, or biosynthesis of proteoglycan, to increase disc height to treat facet pain, which afflicts 15-40% patients. DHF aims at the unmet need of 70-80% back pain market due to early disc degeneration.
5. What are your anticipated funding needs?
In-vitro, sheep and human pilot studies have been completed. To conduct an adaptive clinical study with flexible evaluation for the FDA approval and CE mark, approximately $15 M is needed to treat the majority of back pain patients who suffer from early disc degeneration.
Congratulations and good luck to Aleeva Medical, and be sure to stay tuned to catch the other 14 finalists winners featured on MedTech Boston!M2D2 will be hosting the 2014 New Venture Competition Showcase Event on Wednesday, March 26, 2014. Novel medical device technologies will be presented, followed by a poster and networking session. The grand prize winner will be announced at the follow up winner’s ceremony on April 8th at the offices of Nutter McClennen & Fish in Boston from 4 pm to 8 pm.
At MedTechBoston, we are sharing stories about cutting-edge medical innovation. As Managing Editor, I help coordinate our coverage of hackathons and company profiles. I also create content, update our social media and scout stories. I'm part of an ambitious group of people hoping to inspire a tech revolution in medical care.
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