AFTER THE ELEVATOR PITCH

Adlore, Inc is a Kalamazoo-based start-up developing a smart boot to improve diabetic foot ulcer (DFU) healing rates and reduce treatment cost.

The company’s founding idea is based on research conducted by Daryl Lawson PT, MPT, DSc – one of the company’s founders. Dr. Lawson has treated chronic, non-healing wounds with a combination of electrical stimulation and heat to reduce inflammation and increase blood flow. His approach has improved non-healing DFU healing rates up to 70% vs. 25% when using the standard of care.

The device Adlore is developing – SenLoreTM - will combine the current standard of care – offloading weight from the DFU - with electrical stimulation, heat and sensors to monitor wound conditions and patient compliance. Monitoring wound conditions expands potential treatment efficacy for patients who don’t live near a wound care center.

Adlore has developed a prototype boot and conducted a pilot study on diabetic patients to confirm that the data match the past clinical studies by Dr. Lawson. The pilot study data demonstrated significantly increased blood flow vs. baseline, and was comparable to 6 peer-reviewed clinical studies done in the past. An additional study focused on healing rates showed wound size was reduced 54% after 4 weeks vs. 25% with the standard of care. Proof-of-concept has been demonstrated, and patents have been issued. Adlore is now focused on developing a marketable device, complete process/product verification and validation, completing clinical studies, and obtaining FDA 510(k) approval. The business model is to sell Adlore to a wound care company following FDA approval.

BioMEMS Diagnostics, Inc. is a Michigan-based in vitro diagnostics startup developing a breakthrough testing platform to deliver high-need, high-complexity diagnostics at point of care, at home or at point of need.

The firm has developed a biomarker-agnostic, biofluidagnostic, biomedical microelectromechanical sensor array that vastly improves upon the processing speed and sensitivity of immunoassays and nucleic probes. Instead of designing an expensive, single-purpose chip or sensor for specific diagnostic targets, the hybrid BioMEMS test platform can accept and optimize 200,000+ commercially available, clinically relevant antibodies or probes, with the potential to quickly develop hundreds of new tests while exponentially driving down the cost of manufacture and administration. This contemplates a massive shift in the creation and deployment of POC and OTC diagnostics.

The company is actively pursuing collaborations, project funding, strategic partnerships, and co-ventures to demonstrate the capabilities of its patent-pending diagnostics platform. The R&D effort is led by Chief Science & Technology Officer Michael J. Pugia, Ph.D. The prospective applications include infectious disease, metabolomics, fertility, healthy aging, nutritional biomarkers at point of care, at home or public health screening.

BioMEMS has also formed an affiliate entity – NOXBOX, Inc. to develop and market a 5-minute concussion test that can be administered at point-of-need – a sporting event, accident scene, nursing home, ambulance, industrial clinic or ER, with definitive results immediately available and ported to any paired smart device.

Founder & Executive Chairman Andrew A. Dahl is managing the capital campaign and corporate relationships for BioMEMS and NOXBOX.

Denovo Fertility is a virtual wellness program that nurtures couples with fertility issues through a dynamically guided coaching approach. Through evidence-based education regarding nutrition and hydration, stress management, sleep, joyful movement, and relationships, members of the program meet in a supportive online community allowing for an understanding that fertility IS achievable.

The company’s unique team-based approach includes coaches specializing in different areas to meet members where they are on their wellness journey. Not only are the ‘basics’ taught, but special attention has also been placed upon how to measure progress with devices and apps, provided to members within the company’s global program. Methods of how to utilize these new skills are reviewed and different success stories are shared within their support groups weekly in a positively reinforced environment. As it is well known that community support assists a body’s perception of being safe and out of ‘fight or flight’ mode, this is a mainstay for every member.

In addition to weekly classes and community groups, a virtual community is also available to all members in order to keep the community together throughout the week between classes.

Denovo Fertility is working toward its long-term goal of positively impacting transgenerational health by making these changes attainable in this safe and impactful community. After conception, Denovo Fertility’s allencompassing programs extend through pregnancy as well as post-partum for both moms and dads. The company is driven to provide a complete wellness model and is currently planning for it’s scaling due to anticipated growth.

GeneToBe, a University of Michigan gene therapy startup, seeks cures for genetic diseases. GeneToBe has two gene therapy approaches. The first is a next generation CRISPR/ Cas9 platform, known as Mi-Cas9, a highly efficient and accurate gene-editing tool that allows disease-altering modifications by changing existing DNA in a living organism. AAV, viral-like particles, and liposomes for Mi-Cas9 delivery are being evaluated in proof-of-concept studies of gene-editing therapy.

The second technology is precision-medicine small interfering RNA (siRNA). siRNA targets undesirable mRNA, preventing protein translation. Two variants of Patatin-Like Phospholipase Domain-Containing Protein 3 (PNPLA3); a desirable (I), and an undesirable (M) form exist. In humans, 34% are heterozygous (M/I), and highly susceptible to fatty liver disease, alcohol-associated hepatitis, cirrhosis and liver cancer. A precise siRNA drug only targeting the M isoform PNPLA3 mRNA has been designed. Transgenic PNPLA3 human M form mice, when treated with the precision siRNA drug candidate prevents fatty liver formation. IND-enabling studies for the siRNA program are planned.

GeneToBe also creates translational animal models of human diseases, used for preclinical evaluation of therapeutic agents. Rabbit models of two deafblindness diseases, Usher Syndrome Type 2A and Type 3A, and defective and deficient Cystic Fibrosis have been created. These models are used to understand disease natural history, develop therapies, and identify surrogate markers that may be valuable in the clinical setting. GeneToBe seeks partners for existing programs and to develop future gene-editing targets and animal models.

Innsightful is an early-stage health tech company focused on improving access and efficacy of mental health care.

Innsightful provides an inexpensive, integrated endto-end digital health solution to help people manage stress and prevent stress-induced mental health issues. The company’s solution utilizes off-the-shelf wearables for biomonitoring accompanied by its app to detect users’ hourly levels of stress, anxiety, and depression. The app facilitates a short AI-based dialog with users to determine the causes of stress and their associated emotions. Innsightful then provides the user with

just-in-time (JIT) therapy to reduce the effects of their stressors immediately. These results can be reported to a care team on a daily or weekly basis for intervention.

Using an off the shelf wearable, Innsightful has been able to create AI algorithms that provide measurements of anxiety and depression that are highly correlated with clinical measures of anxiety and depression. Innsightful will be submitting a presubmission letter to the FDA for determining their requirements for a Class 2 submission for a wearablebased screening device for anxiety and depression.

Aer Sol E

Inspire Rx, LLC

According to the World Health Organization, over 100,000 healthcare workers died between Jan 2020 and May 2021 due to COVID-19 in the U.S. and millions died alone as their loved ones were not allowed by their side. To prevent transmission of virus, at the height of Covid-19 pandemic in 2020, Inspire Rx LLC, in collaboration with clinicians at the University of Michigan developed a novel device, called AerosolVE™ BioHelmet, to protect health care workers or anyone in the vicinity of a patient with respiratory infectious disease while enabling non-invasive (sparing ventilators) means to provide supplemental oxygen via nasal cannula or CPAP. In early April 2020, the Aerosolve BioHelmet was successfully used at the University of Michigan Hospital System to treat Covid-19 patients noninvasively without ventilators.

The BioHelmet is a personal, compact, portable, and inexpensive negative pressure barrier environment enabling treatment in field hospitals, ambulances, etc. Worn by the patient, the AerosolVE™ BioHelmet, using

negative pressure, directs exhaled air through a HEPA filter that contains infectious particles, preventing transmission to front-line workers and others, while sparing negative pressure rooms and ventilators. Serving as a “PPE for the Patient”, the BioHelmet enables “quarantine in plain sight”. The BioHelmet is designed to provide safe transportation via ambulance, ship, aircraft, or helicopter, allowing critical staff to maintain station. It permits personal mobility and reduces infrastructure downtime and decontamination costs.

The Aerosolve BioHelmet would be an invaluable therapeutic adjunct for any respiratory infectious disease such as tuberculosis, SARS, MERS etc. or a future pandemic.

MAFEREB LLC

MAFEREB LLC is an African American woman owned life sciences start-up with a long-term goal of commercializing an efficacious, safe pharmaceutical formulation that provides targeted delivery of therapeutic molecules for chronic kidney disease (CKD) management, thus leading to reduction in morbidity and mortality rates of chronic kidney disease nationally and possibly globally. Chronic Kidney Disease is currently considered a progressive disease with no cure, and in some patients will eventually lead to End-Stage Renal Disease (ESRD), thus necessitating dialysis or a kidney transplant. It is being proposed that the formulation would stop disease progression, treat chronic kidney disease, and possibly reverse the disease process. The key differentiator of MAFEREB’s technology is that it will provide targeted delivery of therapeutic molecules in novel drug delivery systems (NDDS).

MAFEREB LLC is located in Michigan Life Sciences and Innovation Center (MLSIC) in Plymouth, Michigan and SPARK East Innovation Center in Ypsilanti, Michigan. Founder & CEO Joan Onyebuchi Erebor, PhD, MPhil, BPharm, CAPM, PMP has combined experience of over 20 years in the pharmaceutical industry, academia, pharmaceutical science research, retail pharmacy, and formulation. Co-founder/CFO Peter Omoruyi Erebor, MBA, PGDCompSci, BSc, CDPSE, has over 20 years of combined experience in accounting, Information technology and business administration. He has been involved in various start-ups and management of small businesses.

MAFEREB LLC proposes that if its therapeutic formulation is commercialized, it could lead to a paradigm shift in how chronic kidney disease will be managed in the US and possibly globally, thus saving lives.

Nitric oxide (NO, not N2O the laughing gas) is a critically important molecule found throughout the body. It functions as a virucide, bactericide, angiogenic, vasodilator, and antithrombotic. NOTA plans to enter the market with its light-activated LANORTM System that uses a simple chemical film strip to generate NO on-demand when exposed to its incorporated LED lights. This system will launch in 2025 for the FDA approved Persistent Pulmonary Hypertension in the Newborn (PPHN) indication, which is not expected to require clinical trials. LANOR’s price point, that is ¼ to 1/10 of competitive systems, its incredibility small size, long-lasting cartridges, and ease of use, make it ideal for both hospital and ultimate home use (COPD).

Today’s NO products are offered on a rental basis and currently generate ~$800M in annual revenues. While the market continues to grow at a solid 7.4% CAGR, there are currently over 400 active clinical trials that will cause the market to explode in the next 3-5 years.

NOTA has been financed by over $6M of NIH grants and by a $2.5M investment from Pegasus Tech Ventures of San Jose, CA. The company has also received a Term Sheet for it’s next $6M round it plans to close by May. In addition, NOTA closed on a corporate partnership with NGK Sparkplug’s Medical Division in 2022, who are assisting with engineering and in-home distribution. NOTA is also working with Prof. Robert Bartlett’s at UofM on NO’s application in open-heart surgery and to extend the viability of donor organs.