HypoHolder prepares for launch

Karen Orr has been a physician assistant for more than 20 years. Over the course of her career, she was accidently pierced with a contaminated needle three times while treating patients.

One of those times, she was stuck by a needle that was used on a patient with uncontrolled hepatitis C. When Orr saw the contaminated needle enter her hand, her heart sank. An estimated 3.2 million Americans are infected with hepatitis C and annually and 15,000 die from hepatitis C-related liver disease. She prayed she would not be among those lost to the blood borne disease as she washed her wound.

She received immediate treatment, but it still took a month of tests for her to discover if she had contracted the disease. It was a traumatic month for her and those who love her.

“There are 550 known sticks a day in the United States, but studies show over 55% (of accidental needle sticks) go unreported. So, in reality, you’re talking over 1000 a day, and that’s just in the United States. This is a global problem.”

Orr is convinced this is a problem she can solve. She created HypoHolder to ensure medical professionals can safely dispose of sharps without risking their health. The device prevents accidental needlesticks when a syringe is being recapped before it is discarded, the time when most sticks occur.

She describes the device as “crazy-simple.” HypoHolder is a metal device that is affixed to a medical procedure tray using magnets. The device holds a square of foam with precisely measured slot designed to firmly grip a syringe cap. The medial professional inserts the capped syringe into the device. When the syringe is ready to use, it is removed from the device, exposing the needle, and leaving the cap embedded in the foam. When the needle is ready to be discarded, it is inserted back into the device, recapping the needle. The syringe and the foam are then safely disposed of.

Orr co-founded the company in November 2021 with orthopedic surgery physician assistant Megan Swift and Dr. Doug Arnold, an orthopedic surgeon.

The company has a strong plan for customer acquisition.

“The top five groups that suffer needle stick injuries right now are dermatology, plastic surgery, ambulatory surgery centers, dental and oral maxillofacial clinics. The other interesting thing about those folks is that they have independently owned clinics. The physicians own it, and they can make their decisions. We plan on talking with them…It’s not a 12-to-18-month committee churn where you’ve got to get approval and get on the budget. They can buy right from the get-go,” she said.

“We want to help our military personnel… we know that in the civilian life needle stick injuries occur, they occur as much and more so when you are in active combat… When you are in active combat, things are hectic and needlesticks occur… (there are) two things that are different with when you’re in active combat is that sharps injuries are much more common, but then secondly, the person they might be helping could be a Nigerian or an Afghani and you have no idea what you just got stuck with. We know we want to help everybody, and we also know that the government will be part of our plan. It’s just that takes a little bit longer.”

Orr explained that building HypoHolders in the Midwest is very important to the company founders. She is currently in talks with a contract manufacturer in Ohio with experience in both medical devices and magnets to manufacture the device.

The company participated in the Ideadvance program through the University of Wisconsin’s Center for Technology Commercialization. The team is now calculating its next steps. At the top of the list is registering the product with the Food and Drug Administration.

According to Orr, HypoHolder is classified as a Class I exempt medical device. Class I devices are considered to be low risk devices, therefore are subject to the fewest regulatory requirements. Class I exempt medical devices are not required to submit a premarket notification application for FDA clearance or approval for market. As a result, the company will be able to legally sell HypoHolders shortly after the regulatory paperwork is filed.

To watch the growth of this emerging company, follow HypoHolders here.