What is Bittylab?
Bittylab, LLC, is a WBE, WOSB-Certified, and Latinx-led and founded MedTech, NY-based startup that designs and develops feeding products for infants with GER*, GERD*, and feeding complications such as gas, colic, and recurrent spit-ups. (*gastroesophageal reflux disease.)
Current industry landscape
GER is incredibly painful for any patient, yet infants endure the agonizing experience for months. GER symptoms include vomiting, poor weight gain, dysphagia, esophagitis, abdominal pain, and hours of inconsolable crying, also known as colic. The recurrence of GER leads to GERD. GERD shows evidence of irritation to internal organs due to constant acid regurgitation, cough, laryngitis, and wheezing (stridor). Other complications include dental erosions, pharyngitis, sinusitis, pneumonia, and recurrent otitis media1.
Statistics show that over 85% of premature infants plus 66% of full-term infants exhibit GERD symptoms1. Pediatric guidelines and common interventions, such as prescription drugs are ineffective and render a long list of side effects. The safety and efficacy of the available FDA-approved drugs have not been established in children less than one year of age. The lack of effective treatments leads to multiple doctor visits, specialist referrals, ER admissions, hospitalizations, and increased NICU stay. Infant GER and GERD are single-handedly responsible for a $41 Billion annual expense in the US alone. This void creates a multi-billion dollar Total Addressable Market opportunity for Bare®Rx in the US.
What competitors exist?
Products targeting GER and GERD in babies are: Prescription drugs, Baby formulas, OTC medication, supplements and baby bottles. However none of these are proven effective and many cause serious side effects.
Prescription Drugs: While prescription drugs are FDA approved to be used in adults, the safety and efficacy of these drugs have not been established in children less than one year of age. Prescription drugs such as PPI (proton pump inhibitors and H2 blockers) are ineffective and cause dangerous side effects. These include lethargic behavior, blood in the stool, liver disease, bone fracture, pneumonia, gastroenteritis, candidemia, and necrotizing enterocolitis in preterm infants. The latest pediatric guidelines are no longer recommending the use of prescription drugs due to the harmful side effects. In 2019, Zantac, the most commonly used drug in infants and preterms, was pulled off the market because cancer-causing contaminants were found.
Expensive branded infant formulas: There is no indication or FDA approval on baby formulas. Via marketing, they express anti-GER or anti-GERD claims as well as allergies.
Supplements: Despite the hype of probiotics, there’s no evidence that they help with GER or GERD symptoms in adults, let alone infants. However, they aggressively market to infants with GER and GERD. Any unregulated ingestible is not recommended for infants.
Why Bittylab was created
Bittylab started at Priska’s kitchen table with her hand-made prototype after her baby began to show high symptoms of GER. After a successful ecosystem of customer-based R&D and leveraged cost-effective awareness campaigns for the consumer market, Bittylab reached a groundbreaking clinical discovery in the seventh year; Bare® Air-free significantly reduced GER and GERD symptoms in 75% of babies in the first two weeks. The Bare® Air-free technology has been published in major news outlets such as CNBC Viral Video reaching 29+M views, Thrive Global, a special feature on leading women in STEM by International Edison Awards. Bare® Air-free has won the GOLD Edison Award for design and innovation, was a finalist at the 2017 IDEA (International Design Excellence Awards for Industrial Designers) and was a pre-sale item that raised $50,000 in the first 48 hours.
Bittylab is on a mission to help 1,000,000 babies! Here in the USA, there are 4 million babies born a year. According to the National Institutes of Health, 66% of — otherwise healthy — infants suffer from the painful symptoms of GERD. With nothing in the market that can effectively help two-thirds of the infant population, Bittylab is taking on the job to provide these infants with a science-backed effective product. Bare® Air-free has already helped tens of thousands of babies get rid of reflux symptoms.
Bare® Air-free differs from competitors because its efficacy is proven by science. The combination of its unique benefits, air-free feeding, upright feeding position and flow & pace control, are clinically proven to reduce severe gas, spit-up, daytime fuss, midnight colic, GER, GERS & diagnosed GERD.
Success so far: The Bare® Air-free technology has been published in major news outlets such as CNBC Viral Video reaching 29+M views, Thrive Global, a special feature on leader women in STEM by International Edison Awards. Bare® Air-free has won the GOLD Edison Award for design and innovation, it is part of the permanent gallery at RedDot21; and was a finalist at the 2017 IDEA (International Design Excellence Awards for Industrial Designers). A pre-sale that raised $50,000 in the first 48 hours went viral by syndicated Entrepreneur Magazine, reposted by Fortune Magazine, CNN Money, CBS, Huffington Post, among others.
The company’s vision is to bring this product for in-hospital and at-home use. Due to the clinical benefits shown in the clinical study, Bittylab is currently in the process of regulatory compliance. Bare® Air-free aims to become the first low-risk and non-pharmacological medical device for treatment and prevention of infant GER and GERD.
“Extreme gassiness, micrognathia (recessed jaw), high palate, weak tongue function, and central sleep apnea. It was very difficult to feed until Bare® Air-free. I was amazed after the first feeding I gave him. He took to it
instantly and it took him maybe 10 minutes to feed him when it normally takes 40.” - Hannah Riley
Check them out: https://www.bittylab.com/
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