Funding
• Newport Beach-based Amnion Life, which develops incubation technology for premature babies, is seeking $200,000 on Wefunder to help bring its product to market.
Proceeds would support clinical trials.
The company, founded two years ago, has raised over $1 million.
Chief Executive Amir Fassihi founded it to develop AmnioBed, a fluid-filled neonatal incubator system that recreates a habitat closer to in-womb.
He’s a practicing radiologist with expertise in medical imaging and ultrasound.
“Premature infants have very thin skin, [with] blood vessels close to the skin, [which makes them] susceptible to heat loss and dehydration,” Fassihi said.
He said the company believes that placing infants in a very warm bath similar to that of a womb—amniotic fluid keeps infants at a 98-degree temperature—would help decrease complications associated with premature birth, decrease days of stay in neonatal intensive-care units, and improve outcomes.
The U.S. ranked sixth in the world with 388,130 premature births, according to a 2016 report from the Centers for Disease Control and Prevention. More than $43 billion is spent annually in the U.S. to care for premature infants; the average cost per day for an infant in an intensive care unit is $4,000.
The company said currently available options are insufficient: conventional warmed incubators that use a plastic hood to provide heat and artificial humidification, and radiant warmer beds that use an electrically heated metal alloy wire coiled within a quartz tube to absorb infrared energy and convert it into radiation.
Its device features medical-grade water filters that eliminate heavy metals, contaminants and bacteria; a dosing pump that mixes calculated, personalized electrolyte solution; a safety chest and pelvic harness to keep the infant’s head above water; and audio and video for parents to talk to and monitor the infant.
It makes its preclinical-stage device in the company’s research and development facility in Pozega, Serbia.
Amnion Life currently has a workforce of about 30, 12 of them full time employees. Fassihi said the company plans to hire more people when it closes the round.
• Cerenetex founder and Chief Executive Benjamin Bobo pitched to the crowd at a recent MondayClub event on the Newport Beach-based company’s preclinical device—“a stethoscope for the brain using noninvasive diagnostics using AI.”
The screening device-headphone is designed to pick up acoustic signals generated by cerebral hemodynamics to help doctors determine if a patient is suffering from a migraine or something else.
The company wants to raise $2 million in a seed round with a minimum investment of $25,000. Proceeds would support product development and clinical efforts. Its first Food and Drug Administration indication would relate to treating migraines.
Bobo estimates the U.S. addressable migraines market is at least 4 million people.
“It’s a fascinating idea … we have no physiologic measurement of what pain is,” said Chief Medical Officer John Chen. He’s a neurologist at Santa Ana-based KPC Healthcare Inc. and at his own clinic in Orange.
He said he sees about “750 patients in any given month with chronic migraine headaches” and that the challenge for him becomes, “How can I truly separate someone with a bad headache versus someone with something completely different?”
Bobo said diagnosis and treatment of headaches, particularly migraines, is a multibillion-dollar problem for the healthcare system. Care providers, including neurologists, primary care and emergency room physicians, need a better, lower-cost and nondrug solution, he said.
“I will tell you in hospitals when [people] get headaches and they come into ER, we have to treat every headache as a high emergency,” said Suzanne Richards, senior adviser with KPC Healthcare. She served as chief executive of the for-profit seven-hospital healthcare system, which has four locations in OC, from 2014 to this past July.
“You might be sitting there thinking that you just have a headache, but we have to rule out everything, MRI, CT scans … we have to be overly careful in our assessment because we don’t want the slim chance that you have some cerebral disease and you walk out the door [without us detecting it],” she said.
The per-person spend on headache screening is $2,000 to $5,000 per emergency room visit, according to Richards.
She said they’re real-life emergency-room scenarios that can benefit from a technology like the one Cerenetex is developing.
The company plans to first seek regulatory clearance as an information gathering device, with the goal of developing next-generation versions that could provide diagnosis and even therapies.
Bobo co-founded the company with Dr. Mohsin Shah, who serves as chairman. Shah is a neurosurgeon and neurologist with a focus on neurovascular disorders, neurotrauma and neurocritical care.
— Sherry Hsieh
