Unique technology, amazing people
iota Biosciences is made up of a proudly diverse team of exceptional people. We come from different backgrounds and bring different skills, but we all share a passionate belief in the power of innovative bioelectronics to improve health and transform lives. As a team we work collaboratively and cross-functionally, with a strong connection to doctors and patients, to ensure that what we are developing is aligned with their core needs. We continually challenge what’s possible and inspire each other to think differently as we create and design cutting-edge technologies with the potential to change lives.
Speed without compromise
We know that some patients don’t have time to wait. Driven by passion and tenacity, we combine a rigorous focus on quality with the agility and adaptability to keep moving our ideas and innovations forward, fast.
“We have a culture of moving fast and embracing change. iota allows everyone to maintain their individuality while adhering to quality practices.”
Meet our leadership team
Mike Woods, MD
Chief Executive Officer
Mike Woods has spent his career at the intersection of medicine, innovation, and business. As a board-certified surgeon and healthcare executive, he brings firsthand clinical insight alongside leadership experience from startups and global industry leaders including Johnson & Johnson and Novartis. His expertise in translating medical needs into successful commercial solutions makes him a valuable advisor and strategic leader.
Lusin Markaryan
Senior Director of Regulatory Affairs
Carmela Cusumano
Director of Clinical Operations
Mike Woods, MD
Chief Executive Officer
Mike is a fellowship-trained, board-certified surgeon who obtained his BSc in cellular biology and MD and surgery degrees from the University of Kansas and an MBA in medical management from the University of Southern California. His career spans clinical surgery, leadership roles in surgery, health systems, healthcare start-ups, medical software and data science, and global pharmaceutical development.
He is excited about helping the iota team bring the Akyva device to market to help millions of patients with underactive bladder lead more normal lives.
Lusin Markaryan
Senior Director of Regulatory Affairs
Lusin Markaryan brings over 20 years of medical device experience in regulatory affairs, quality systems and clinical strategy to iota Biosciences. She has a proven track record of guiding novel technologies through complex regulatory pathways and implementing quality frameworks that support every stage of Class III device development. Prior to joining iota Biosciences, Lusin held senior leadership roles at SetPoint Medical and Medtronic Diabetes. At SetPoint Medical, she directed global regulatory strategy and secured key first-in-human and pivotal study approvals for a pioneering bioelectronic therapy.During her tenure at Medtronic, she led multiple successful PMA submissions - including an original filing - and managed both BIMO and QSIT audits.
At iota Biosciences, Lusin oversees the Quality and Regulatory Affairs organization, driving strategic alignment across development, manufacturing, and clinical functions. Her focus is on accelerating innovation through efficient regulatory execution while ensuring patient safety through a disciplined, risk-based quality framework.
Lusin holds a Bachelor’s degree from the University of California, Irvine and a Regulatory Affairs Certification (RAC- US & EU).
Carmela Cusumano
Director of Clinical Operations
As Director of Clinical Operations, Carmela leads the team responsible for planning, executing, and managing iota’s clinical programs. She oversees all aspects of clinical trial strategy and delivery, ensuring the ethical, efficient, and high-quality execution of studies that advance iota’s innovative therapies toward patients.
Carmela brings more than 20 years of experience in clinical research, with a focus on medical device development and IDE studies for Class III devices. Her career spans all phases of product development, from early feasibility through pivotal and post-market studies.
Prior to joining iota, Carmela held leadership roles in clinical operations across multiple medical device companies, where she helped guide new technologies from concept to commercialization. She earned her M.S. from Drexel University College of Medicine.