Startup aims to take pain, fi­nan­cial strain out of brow lifts

Northwest Arkansas Democrat-Gazette - - BUSINESS & FARM - JOE CARLSON

MIN­NEAPO­LIS — Zift Med­i­cal has a small foot­print, but it’s hop­ing to make big changes in aes­thetic medicine.

The 4-year-old med­i­cal tech­nol­ogy startup has es­chewed staff in fa­vor of con­tract work and out­sourc­ing. Rather than cre­ate a head­quar­ters, Zift is crash­ing with col­leagues at Res­o­lu­tion Med­i­cal who had ex­tra of­fice and clean-room space in sub­ur­ban Min­neapo­lis. In­stead of pin­ning its hopes on ven­ture cap­i­tal, Zift Med­i­cal is rais­ing money it­self and spend­ing ju­di­ciously.

The re­sult is that the twop­er­son startup has con­ceived, de­signed and be­gun hu­man test­ing of a tiny med­i­cal de­vice while rais­ing $3 mil­lion. Zift hopes to sell the de­vice one day to an es­tab­lished player in aes­thetic medicine, like Bo­tox-maker Al­ler­gan or breast-im­plant maker Sien­tra.

Zift’s de­vice, which is about the size of a gnat when im­planted, is in­tended as a cheaper, less painful way to get brow-lift surgery. On­go­ing ex­per­i­ments will de­ter­mine how long it works. But even Zift’s first-in-hu­man ex­per­i­ments are dif­fer­ent from stan­dard in­dus­try prac­tice, thanks to a Food and Drug Ad­min­is­tra­tion pro­gram that is al­low­ing the first im­plants to hap­pen in the U.S. in­stead of over­seas.

“Ini­tially, we were think­ing we’d end up in Paraguay or some­thing for the clin­i­cal trial,” said Zift Med­i­cal Chief Ex­ec­u­tive Of­fi­cer Eric Simso, an in­dus­try vet­eran who founded the com­pany with en­gi­neer and fel­low med­i­cal-tech­nol­ogy vet­eran David Blaeser. “It is so nice to be able to go across town [to view] a pro­ce­dure, and then the fol­low-up is all done.”

Zift Med­i­cal used an al­ter­na­tive path­way to get the FDA to ap­prove its first-in-hu­man study. Known as an “early fea­si­bil­ity study in­ves­ti­ga­tional de­vice ex­emp­tion,” the ap­proval is al­low­ing Zift to do its ini­tial pi­lot study of 20 peo­ple from Min­nesota and Wis­con­sin to gather early data on proof of prin­ci­ple and safety.

Ul­ti­mately, the com­pany’s ap­proach and cost struc­ture will mat­ter less than the ques­tion of whether the Zift de­vice works as in­tended.

The de­vice con­sists of a thin niti­nol tube about as wide as the tip of a dis­pos­able pen, which is placed in a mil­lime­ter-wide “in­ci­sion” in the fore­head and then fired a few mil­lime­ters into the skull us­ing a hand-held tool that looks a bit like a glue gun.

With the fore­head skin pulled taut and the bone an­chor in place, the tool is with­drawn and sev­eral curved “petals” of metal flex out from the thin tube and in­vis­i­bly grab onto tis­sue above the eyes. The an­chors then hold the top lay­ers of skin more taut than be­fore, the­o­ret­i­cally cre­at­ing the same kinds of re­sults as a tra­di­tional sur­gi­cal brow lift but with­out the pain, ex­pense or ex­ten­sive post-sur­gi­cal bruis­ing.

Al­though it’s tough to give spe­cific price es­ti­mates for a pro­ce­dure that’s not even proved safe yet, Simso said the ul­ti­mate goal is to have a “Zift Lift” — the com­pany’s cur­rent name for the pro­ce­dure — cost a third of a tra­di­tional open-sur­gi­cal or la­paro­scopic brow lift.

As of ear­lier this month, five pa­tients have had the Zift pro­ce­dure. It typ­i­cally in­volves im­plant­ing six to eight an­chors, which are in­tended to be per­ma­nent even though soft tis­sues age and de­velop lax­ity over time.

Prin­ci­pal in­ves­ti­ga­tor Peter Hil­ger, a fa­cial plas­tic sur­geon and Univer­sity of Min­nesota pro­fes­sor, said

it’s too early to say how long the an­chors will main­tain the pa­tient’s de­sired lift and how that time frame com­pares to a tra­di­tional sur­gi­cal brow lift.

“You might le­git­i­mately ask me, are those go­ing to be enough to hold up the weight of the skin over the long term? I don’t know the an­swer to that,” Hil­ger said. “I do know it held at 90 days [in an­i­mal stud­ies], and it is hold­ing a week af­ter­ward in pa­tients. But … it’s a first-in-hu­man study.”

The on­go­ing fea­si­bil­ity study will look at re­sults at 90 days, six months, and an­nu­ally there­after, po­ten­tially lead­ing to re­fine­ments in im­plant tech­nique and de­vice de­sign. At some point the com­pany will also launch a larger clin­i­cal trial to gather ex­ten­sive data on safety and ef­fec­tive­ness that can be used to get full com­mer­cial clear­ance, likely through the FDA’s 510(k) pro­gram.

Al­though the 510(k) path­way

isn’t known for re­quir­ing ex­ten­sive pre­clear­ance test­ing, Simso and Blaeser said strong data will en­sure that the de­vice is safe while also mak­ing the com­pany more valu­able in the process.

So far Zift has raised its funds mainly through “an­gel in­vestors” in Min­nesota. One near-term goal is to at­tract the in­ter­est of “strate­gic” in­vestors like big, es­tab­lished med­i­cal-tech­nol­ogy com­pa­nies that could of­fer mod­est fund­ing up front while help­ing di­rect Zift’s fu­ture. One day a full ac­qui­si­tion by an in­vest­ing com­pany could be pos­si­ble, though Zift is also work­ing on plans to go it alone if need be.

Simso said the com­pany has de­lib­er­ately avoided ven­ture cap­i­tal thus far, be­cause ven­ture cap­i­tal firms typ­i­cally de­mand some level of con­trol over the com­pany and may end up with terms that greatly di­lute orig­i­nal in­vestors’ hold­ings.

“Ven­ture is not bad nec­es­sar­ily,” Simso said. “You just need to know that it’s not free money by any means.”

Star Tri­bune/CAR­LOS GON­ZA­LEZ

Zift Med­i­cal is get­ting FDA ap­proval for a tiny hook, im­planted through a small in­ci­sion, that at­taches brow tis­sue to the skin.

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