Flowonix raises $40M to support next-generation infusion pump with improved MRI compatibility

Flowonix's Prometra--Courtesy of Flowonix

Flowonix, maker of the implantable Prometra infusion pump for chronic pain patients, announced that it has raised $40 million in debt and equity financing, led by private equity fund Élevage Capital Management. The Prometra delivers the generic drug morphine, commonly marketed as Infumorph, to the intrathecal space in the spine because that is preferable to systemic delivery, according to the company.

In an interview with FierceMedicalDevices, company CEO Steve Adler said that half of the funding is in the form of equity and the other half is debt. The debt was provided by new investor Hercules Technology Growth Capital, which provided $15 million in debt financing and a conditional accounts receivable line of up to $5 million to cover the lag between production and product reimbursement.

Adler said the company will use the proceeds to approximately double the size of the sales and marketing force and build out related infrastructure, such as educational programs. Clinical trials to demonstrate long-term outcomes and expand the device's indication for use are also planned, he said.

"We look forward to providing additional details on these efforts, which will include patients suffering from cancer pain as well as those who fail other implantable treatments," Adler said in a statement.

During the interview, the CEO added that the FDA's review of Flowonix's PMA supplement for the next-generation Prometra II is progressing well. He previously told FierceMedicalDevices that the big advancement of the upcoming version will be improved MRI compatibility, as Flowonix tries to differentiate its product from Medtronic's SynchroMed II, which also touts its MRI compatibility on the product website.

This time around he elaborated further, saying Prometra II is "designed so that the physician doesn't have to take the drug out of the pump prior to the MRI." Removal of the medication is required in the current version of Prometra, which is MRI-compatible when the pump is empty, Adler said. The other proposed upgrades in Prometra's PMA supplement include new controllers for the patient and clinician, as well as enhanced bolus delivery modes for rapid intravenous delivery.

And work has begun on further improvements in the Prometra III, though Adler wouldn't specify what the changes are, or when that product might hit the market. It isn't expected to occur soon, given that Prometra II is still under FDA review.

In total, about a dozen companies participated in the latest round of fundraising, Adler said, including Clarus Ventures on the equity side. Hercules contributed equity as well as debt, the CEO said.

"We believe that the Prometra Pump System represents a breakthrough in pump-based drug delivery, and is capable of bringing significant benefit to clinicians and patients alike," said Chad Norman, managing director of Hercules, in a statement. "We are proud to be a capital provider for Flowonix as the Company ramps its commercial initiatives for this unique, value-added technology solution."

- read the release
- here's the Prometra website

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