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BIOFEST INVEST APPLICANT
Health Discovery Labs
- 512 W MLK Jr Blvd #285, Austin, Texas 78701, US
- https://healthdiscoverylabs.com/
Company Contact:
Legal Entity Type: LLC
Company Type: Medical Device
Company Stage: Development
No. of Employees: 3
Desired Financial Amount: $1.5M
Background
Company Background
Early in my career as a clinician and as a nephrologist, I recognized the critical link between the welfare of patients and their recovery which often included time in the ICU. Because of this, and after completing my fellowship at the Royal London Hospital in 2015, I started working, alongside with my brother Alaa Hassan – holder of a Master degree in Electrical Engineering and with more than 10-years of experience in the medical devices industry – on developing an innovative electrical muscle stimulation system that could reduce the time patients spend in the ICU and improve their overall recovery and quality of life.
Management
Alaa Hassan, MSEE: Mr. Hassan has over 10 years of experience in Electrical Engineering. He participated in the development and release of multiple medical devices in the U.S. and worldwide. He previously worked with multiple startups as the engineering lead and occupied multiple roles in R&D, electrical engineering as well as engineering management positions. Mr. Hassan holds a master’s degree in electrical engineering from the University of Balamand in Lebanon. Mr. Hassan will lead the research and development efforts to build the technology.
Oussama Hassan, MD: Dr. Hassan is a Medical Doctor specialized in kidney diseases, dialysis, and organ transplantation. Due to his academic achievements, Dr. Hassan was awarded a grant by the European Renal Association-European Dialysis and Transplantation Association (ERA-EDTA) to conduct a clinical fellowship at the Royal London Hospital/Barts Health NHS Trust. Dr. Hassan participated in multiple local and international congresses as a guest speaker to tackle challenges in the management and care of patients with end stage kidney diseases. He holds a BS degree in Biology and an MD degree from the University of Balamand in Lebanon. Dr. Hassan will lead Clinical development efforts and establish relations with Key Opinion Leaders in the field of ICU Early Mobility and EMS.
Board of directors
we do not have a board of directors – but here is a list of our advisors with a description of their expertise:
Dr. Lisa McDonald is the director of Healthcare Incubation at the Austin Technology Incubator – the startup incubator of UT-Austin. Also Dr. McDonald is the Co-Founder and managing director of Endura Ventures alongside of her husband Dr. Andrew Nerlinger (a VC partner at Bill Wood VC, based in Austin).
Dr. Gregory Pogue is Deputy Executive Director and senior Research Scientist of the IC2 Institute of the UT Austin. He has extensive technology commercialization experience from leading multiple startups into successful exits either by achieving public offering on NASDAQ, or acquisition by a Fortune 500 company.
Dr. Verena Kallhoff currently is the managing director of the Machine Learning Lab & Institute at UTAustin. Before that, she leads the Workspaces at Texas Health Co-Lab at the Dell Medical School. Prior to joining Dell Med, Dr. Kallhoff served as the innovative managing director of CyBHOR, an industry/university cooperative research center sponsored by the NSF. The center focused on using tools of computational surgery to drive improvements in the hospital operating room.
Dr. Mark Nader is board certified in internal medicine and nephrology. His research interests are centered on epidemiology and outcomes, hypertension and CV mortality in the dialysis population, and on improving clinical outcomes in patients with advanced diseases. Dr. Nader completed his internal medicine residency at Mount Sinai Hospital and his Nephrology and Hypertension fellowship at Georgetown University in Washington, D.C. In 2015, Dr. Nader joined Kidney Care Consultants and has been practicing nephrology since.
Dr. Paul Harford is an assistant professor of internal medicine and the medical director of the critical care unit at Dell Seton Medical Center since 2012. Dr. Harford is an attending physician in private practice since 1991 and leads the medical ICU rotation in internal medicine at the Dell Seton Medical Center. He is also partner at Pulmonary & Critical Care Consultants of Austin.
Dr. Linda Chlan is the first associate dean for nursing research at Mayo Clinic. Additionally, Dr. Chlan maintains her own program of research focused on symptom science. Her program of research encompasses testing symptom management interventions with patients receiving mechanical ventilatory support.
Elisa Maldonado-Holmertz is a regulatory specialist with over 25y experience in biopharma and medical device industry. She advises multiple successful medical device companies on regulatory matters. Elisa occupied a VP position at Emergo Group before creating Obelix Healthcare & Biotech Consultancy.
Anthony Rodriguez specializes in commercialization of medical innovations with over 10-years of experience in both large, established and early-stage companies. He most recently helped bring the first endovascular fistula creation device to market with TVA Medical, which was acquired in 2018 by BD. Anthony is currently advising multiple companies and is the Director of Marketing for Laminate Medical Technologies.
Doug Stoakley: With over 25y of experience in executive leadership, building some of the best-known brands in Silicon Valley, Doug spent many years advising a range of startups and entrepreneurs on crafting their businesses and commercializing their technology. Now, Doug is co-founder, President, and COO of ClearCam.
Product / Service
disease area / application
Prevention of muscle weakness in critically ill patients, i.e., mitigation of ICU Acquired Weakness in mechanically ventilated patients.
product / Service
Problem: Patients admitted to the ICU become weak and frail due to ICUAW. ICUAW develops in as little as a few hours after admission to the ICU resulting in loss of 11% of muscle strength per day in mechanically ventilated patients. ICUAW is associated with increased length of hospital stay, hospital acquired complications, prolonged rehabilitation time, and most importantly reduced quality of life. Unfortunately, no effective treatment is available, and efforts are mainly focused on preventive measures such as early mobility (EM). However, EM has its own limitations: EM requires active cooperation of the patient which is not feasible during the first few days of critical illness. Additionally, EM is labor expensive requiring 5 healthcare professionals to mobilize one ICU patient. Further, there is a 7days delay in initiating EM leaving patients bound by immobility allowing the disease to progress.
Hence the need for a new tech for early intervention to mitigate ICUAW.
Solution: To solve the problem, we need to keep muscles active during the early days of ICU stay. This could be achieved by using the Electrical Muscle Stimulation (EMS) Technology.
Our solution is to have one EMS device per ICU bed and one pair of garments per patient (We are calling it the MyokinE system).
The system is automated (closed loop), safe, and easy to install on day “Zero” by anyone in the ICU, in less than 5min and provides a non-volitional muscle exercise strategy during early days of ICU stay without the need for supervision or patients’ cooperation.
technology / ip
Advantage: Closed loop EMS system, with improved electric safety for ease of use in ICU setting with reduced risk of electrical interference with life sustaining equipment.
Currently we have 1 IP granted (patent # 11,426,580)
6 IPs under development
Creating an IP strategy will give a competitive advantage and will make it harder to break into the market especially around the automation/ease of use process.
distribution channels
Plan to reach customers during early stage of commercialization:
• ICU medical conferences – influence decision making in the ICU
• Rehabilitation medical conferences
• Engage influential medical centers in clinical studies – firsthand testing of the system
• Publication in high impact medical journal
• Direct sales strategy at early stage – target hospitals with existing relationship (Mayo Clinic, Dell Seton Medical Center, and St. David’s Healthcare Austin).
market size
Beachhead market is critically ill patients at increased risk of developing ICUAW (e.g., patients receiving mechanical ventilation…) with primary focus on the US market.
Market size:
• More than 6Million patients are admitted yearly to the ICU in the US and are at increased risk of developing ICUAW. TAM calculated at $5.2B/year.
• 2.4Million patients receive mechanical ventilation/year in the US and develop some form of ICUAW. SAM calculated at $2.1B/year.
• 40% of ICUs in the US reported offering some form of early mobility to mechanically ventilated patients (up to 950,000 patients received some form of early mobility). SOM calculated at $0.8B/year.
Note that we understand that ICUAW is a global problem and there is market potential in other markets such as South America, EU, and others… [global market size not calculated]
competition
Direct competitors: Niveus Medical; Restorative Therapies; Liberate Medical: developing electrical muscle stimulation devices.
Future potential competitors: DJO Global: focused on recreational sports and body building.
Indirect competitors: include companies in the field of EM delivering products such as ICU beds, ceiling lifts, mobile mechanical ventilators (Stryker, GE Healthcare, Medtronic).
Competitive advantage of the MyokinE system:
(1) it only takes a few minutes to set up the device and can be installed by existing ICU staff,
(2) does not require presence of a healthcare professional in the field of electrical muscle stimulation to monitor and fine tune the device during the treatment session,
(3) safe to be used in patients with cardiac implanted electronic devices in the ICU.
(4) can be used immediately upon admission to the ICU without any delay facilitating the adoption of early mobility to mitigate ICUAW.
Financials
Desired financial amount
$1.5M
previous funding
Boot strapping – out of pocket – $100K
NIH SBIR grant – $260K [active]
current financials
Monthly burn rate = $20k
Cash available = $200K
financial use
Use of funds include:
– Expend the team
– Complete R&D work for first version
– IP strategy and solidification
– Commercialization and customer development
– Regulatory filing for first version of the device – objective is to seed technology in early adopters
– FDA 510k filing
revenue
Business model is based on cost reduction for hospitals by reducing the inpatient length of stay.
Based on our market research, healthcare executives as well as healthcare professionals are focused on reducing the hospital length of stay. This is due to the fact that hospitals are reimbursed based on fee-for-service. In other words, hospitals are reimbursed a fixed amount of money based on the DRG code associated with the disease treated. Consequently, reducing the length of stay will save hospitals money by reducing the cost of care and increasing bed turnover.
Accordingly, by adopting an effective EM using the MyokinE system, hospitals could reduce the cost of care by around $17,274 per patient.
We adopted a preliminary price of $864 for the MyokinE System (device + garment) per patient per hospital stay. The prelim price is comparable to other medical devices used in the critical care settings.
We are pre-revenue.
exit strategy
While HDL has not ruled out the possibility of growing organically, it recognizes that the highest return on investment would likely come via acquisition. HDL would be a natural target for a number of medical devices in particular ICU device manufacturers such as ICU beds and mechanical ventilators. Additionally, manufacturers of early mobility devices such as ceiling lifts and walkers would be similarly interested in HDL.
Such acquisition would facilitate the process of bundling HDL product alongside other ICU products and would fit into existing sales and distribution infrastructures.
Potential acquirers include Stryker, Medtronic, and GE Healthcare.
Timing for the exit: once R&D is complete and seeded into early adopters, there could be a potential for exit. This would be projected to happen within 3 to 5 years.