Exclusive: Brain surgery device maker Hubly Surgical earns key FDA nod, plots funding round

The company won approval to sell its product on the market.

Exclusive: Brain surgery device maker Hubly Surgical earns key FDA nod, plots funding round

A local startup, which aims to make brain surgeries safer, has just received the green light for its medical device. It is now looking to raise more money this year.

Hubly Surgical is a Halcyon-backed firm with offices in D.C. and Chicago. The FDA cleared the company Thursday to begin selling Hubly Drill. This electric system was designed to help doctors drill more effectively and safely into a skull of a patient without damaging underlying tissues. Casey Grage, the CEO and founder of Hubly Surgical, told us that the company has already 'all parts ready to use' for its 500 first commercial drills.

Hubly has already counted more than 45 hospital accounts who are waiting for federal clearance before they can potentially purchase the device. This group includes Level 1 trauma centres, academic medical center and community hospitals who serve large neurotrauma patients across the nation, including Rochester's Mayo Clinic in Minnesota, Baltimore's Johns Hopkins Hospital, and Chicago's Northwestern Memorial Hospital.

Hubly is partnering with independent regional distributors of neurosurgical devices to expand its product line in these markets. These include MD Surgical Products from Newtown, Pennsylvania, ABS Med Inc., based in Downers Grove and Dallas Precision Surgical LLC.

Grage explained that the idea is to simplify an operation often performed by residents in neurosurgery and physician assistants when a stroke, aneurysm, or hemorrhage occurs. These conditions can lead to spinal fluid buildup, which requires medical staff to drill into the skull in order to drain it.

The $1.4 million raised in a seed funding round, led by Jon Kling (founder and CEO of D.C.-based real estate investment company Municipal), and whose investors include Dr. John Shufeldt (managing director of Scottsdale, Arizona venture capital firm Xcellerant Ventures), is being used to enter the sales market. Hubly now has a total funding of about $3 million. This includes capital from D.C.'s social impact nonprofit Halcyon, which was the first ever fund.

Hubly will use these dollars to invest in manufacturing, sales and marketing. It plans to hire sales representatives for each of the three initial regions.

Grage added that Hubly is also looking to raise a Series A funding round of approximately $5 million in the near future, which will help it expand into these markets and gain more regulatory approvals for their device. Hubly will release different drill bits for various uses. This could include stereo-EEG (used to determine the source of seizures for epilepsy) or deep brain stimulation to treat Parkinson's.

Grage, a 2021 honoree of the 25 Under 25, founded Hubly in Northwestern University’s Kellogg School of Management after taking a class on medical device entrepreneurship. She met Dr. Amit Ayer there, a neurosurgeon who was pursuing his MBA at the medical school of Northwestern University. Together, they developed the drilling system. He was her co-founder. Grage has a Bachelor's degree in Neuroscience from Northwestern University and worked previously as a software developer at JPMorgan & Chase Co.