START-UPS

Five Irish start-ups with in­no­va­tive so­lu­tions

Irish Independent - - MED-TECH -

THE X-BOLT GETS PEO­PLE MO­BILISED QUICKER AND HOME A DAY OR TWO EAR­LIER WITH­OUT FEAR OF THE IN­TER­NAL CON­STRUCT FALL­ING APART

X-Bolt Or­thopaedics

While us­ing an ex­pand­ing bolt to se­cure a plasma screen to the wall of his apart­ment in 2007, founder of X-Bolt Or­thopaedics Dr Brian Thornes had a light­bulb mo­ment – that this type of de­vice would be the per­fect an­swer for fix­a­tion in os­teo­porotic bone such as hip frac­tures.

Hav­ing pre­vi­ously worked as a sur­geon him­self, he knew such pro­ce­dures were prob­lem­atic and be­lieved that pa­tients could be treated bet­ter. So he in­vented the X-Bolt, which is eas­ily ex­panded by the sur­geon us­ing a stan­dard or­thopaedic screw­driver and is fully rev­ersible and re­mov­able.

“While work­ing as a sur­geon I in­vented Tightrope, an an­kle frac­ture im­plant that has since sold more than 180,000 units world­wide. But with X-Bolt I felt I had di­rec­tion in my life and wanted to set up a busi­ness,” he says.

“The big­gest im­pact the X-Bolt can make is in hos­pi­tal wards. Typ­i­cally one third of or­thopaedic trauma beds are taken up by hip frac­ture pa­tients who tend to stay in for two or three weeks. The X-Bolt gets peo­ple mo­bilised quicker and home a day or two ear­lier with­out fear of the in­ter­nal con­struct fall­ing apart,” Brian ex­plains.

A clin­i­cal trial of 100 pa­tients in the UK showed a zero re-op­er­a­tion rate af­ter the X-Bolt de­vice was used, when usu­ally a 5-10% re-op­er­a­tion rate would be ex­pected.

“The re­cov­ery time is roughly the same as be­fore how­ever the pa­tient has a stronger leg to stand on,” Brian con­tin­ues.

“An anal­ogy with the tra­di­tional screw-based method is that it is like ‘wear­ing stilet­tos in mud’ so you tend not to walk heav­ily. The X-Bolt pro­vides a wider anchorage to put more weight through the leg.”

Now fully patented in Europe with a patent pend­ing in the US, the X-Bolt has been used suc­cess­fully in over 200 cases in the UK and Ire­land with the com­pany now em­ploy­ing eight peo­ple.

Sur­gaColl Tech­nolo­gies Royal Col­lege of Sur­geons of Ire­land (RCSI) spin-out com­pany Sur­gaColl Tech­nolo­gies re­cently re­ceived CE mark ap­proval for its bone graft sub­sti­tute Hy­drox­yColl, which was used in the past year to re­build a thor­ough­bred mare’s jaw - ef­fec­tively sav­ing her life and al­low­ing her to win races again.

Hy­drox­yColl and Sur­gaColl’s other in­no­va­tion, a car­ti­lage re­pair scaf­fold called Chon­droColl, are based on tech­nolo­gies de­vel­oped by the Tis­sue En­gi­neer­ing Re­search Group (TERG) at the RCSI, headed by Pro­fes­sor Fer­gal O’Brien.

A me­chan­i­cal en­gi­neer­ing grad­u­ate, Sur­gaColl CEO John Glee­son se­cured a po­si­tion at TERG while do­ing his post-doc­toral re­search and de­cided to set up a spin-out com­pany when he and Fer­gal iden­ti­fied an en­dur­ing un­met need for the prod­ucts that could be com­mer­cialised from their re­search.

In 2012 they raised €2m in seed fund­ing from four main in­vestors in­clud­ing En­ter­prise Ire­land and the AIB Seed Cap­i­tal Fund.

John ex­plains why Hy­drox­yColl im­proves on ex­ist­ing sur­gi­cal tech­niques: “When a bone is dam­aged the stan­dard treat­ment is an au­to­graft, which in­volves tak­ing a piece of the per­son’s bone from some­where else in the body and im­plant­ing it into the site of the de­fect.

“The need to first carry out a sur­gi­cal pro­ce­dure to har­vest healthy bone, and a sub­se­quent im­plan­ta­tion of this har­vested bone, cre­ates an un­nec­es­sary risk of chronic pain and in­fec­tion for the pa­tient. Alternatively, if a sur­geon de­cides to im­plant ar­ti­fi­cial re­pair ma­te­ri­als in­stead of us­ing an au­to­graft, the body’s own re­pair process has to re­gen­er­ate new tis­sue while also fac­ing the chal­lenge of heal­ing the body us­ing ma­te­ri­als that are not nat­u­rally com­pat­i­ble.

“Ortho­bi­o­log­ics [the tech­nol­ogy field Hy­drox­yColl be­longs to] uses nat­u­rally de­rived bio­ma­te­ri­als de­signed to form a scaf­fold to en­cour­age re­gen­er­a­tion sup­ported by dis­solv­able heal­ing pro­cesses – which means the heal­ing process is much faster.”

Now based at the In­vent Cen­tre at Dublin City Univer­sity, Sur­gaColl em­ploys seven peo­ple and ex­pects to dou­ble to over 15 em­ploy­ees in 2016. Hy­drox­yColl EU sales started this quar­ter and Sur­gaColl ex­pects Euro­pean mar­ket ap­proval for Chon­droColl in the first half of 2016. It is also ap­ply­ing for US ap­proval for both of its prod­ucts.

Embo Med­i­cal

Founders of Gal­way-based Embo Med­i­cal Wayne Allen, Colin Forde and Liam Mullins ex­pect that their prod­uct in­no­va­tion Cater­pil­lar will change the whole model in terms of how blood flow in dis­eased blood ves­sels and or­gans (known as em­boli­sa­tion) is shut down dur­ing surgery.

Hav­ing worked in the med-tech in­dus­try for a com­bined 40 years, they left their jobs in three dif­fer­ent med­i­cal de­vice com­pa­nies – Vy­sera Bio­me­dial, Cre­ganna-Tactx Med­i­cal and Veryan Med­i­cal, re­spec­tively – to be­come mem­bers of the first ever BioIn­no­vate Ire­land Fel­low­ship in 2011.

Based on the Biode­sign pro­gramme in Stan­ford Univer­sity in the US, this ten-month spe­cial­ist med­i­cal de­vice in­no­va­tion pro­gramme spon­sored by En­ter­prise Ire­land in­volves teams spend­ing three months in hos­pi­tals ob­serv­ing sur­gi­cal pro­ce­dures and health care pro­fes­sion­als in a clin­i­cal set­ting – an as­pect which par­tic­u­larly ap­pealed to Wayne.

“I would rec­om­mend any­one in­ter­ested in start­ing a medtech com­pany to check out the BioIn­no­vate pro­gramme. Re­cruit­ing takes place on a yearly ba­sis; it’s a solid frame­work, with great ac­cess to help you get started,” he says.

“Em­boli­sa­tion is used in a va­ri­ety of dis­eases in­clud­ing cancer. Dur­ing our three months in St James’s Hos­pi­tal in Dublin we ob­served that the ex­ist­ing tech­nol­ogy used for the pro­ce­dure was not ideal and could have clin­i­cal is­sues and we felt there was an op­por­tu­nity to im­prove things for both the physi­cian and pa­tient.”

The three part­ners formed the com­pany in De­cem­ber 2012 with the help of grant fund­ing from En­ter­prise Ire­land, de­vel­oped pro­to­types and as­sessed the tech­nol­ogy on an­i­mals. Last sum­mer they raised €3m in seed fund­ing and are now pre­par­ing to make a sub­mis­sion for US Food and Drug

Ad­min­is­tra­tion (FDA) ap­proval and their first in-hu­man study.

“The ob­jec­tive of the Cater­pil­lar tech­nol­ogy is to achieve higher safety out­comes in a shorter pro­ce­dure time. We found that 5-6pc of ex­ist­ing em­boli­sa­tion pro­ce­dures cur­rently have is­sues, which would be ad­dressed with our tech­nol­ogy,” says Wayne.

“The stan­dard of care with this pro­ce­dure to­day is to use an av­er­age of nine metal­lic coils per blood ves­sel per pro­ce­dure, whereas the Cater­pil­lar so­lu­tion re­quires one de­vice per treat­ment. This re­duces the time of the pro­ce­dure and is there­fore more cost ef­fec­tive.

“In terms of safety, there are two is­sues with the ex­ist­ing stan­dard of care – coils can move and mi­grate, whereas our de­vice locks into place once it is de­liv­ered into a blood ves­sel. It also has fea­tures to pre­vent re­canal­i­sa­tion, which is where the body tries to break down a clot formed by stop­ping the blood flow. This can cause prob­lems af­ter surgery.”

Embo Med­i­cal cur­rently em­ploys 12 peo­ple at its fa­cil­ity in NUI Gal­way’s Busi­ness In­no­va­tion Cen­tre.

Incereb

Es­tab­lished in Dublin in 2011 by Jim Roche, Incereb has come up with a de­vice to fa­cil­i­tate the mon­i­tor­ing of ba­bies’ brain ac­tiv­ity that can be put on a baby’s head by any­one in a neona­tal ward in a cou­ple of min­utes with no train­ing re­quired.

The Neon uses an ar­ray of sen­sors, which are at­tached to the scalp in a sin­gle ap­pli­ca­tion and con­nected to record­ing equip­ment to mon­i­tor the in­fant’s brain ac­tiv­ity to as­cer­tain func­tion and iden­tify seizures.

It is used dur­ing ther­a­peu­tic brain cool­ing, the stan­dard of care for ba­bies which have ex­pe­ri­enced oxy­gen de­pri­va­tion at birth.

With a back­ground as a neu­rol­ogy tech­nol­o­gist, Jim first recog­nised the need for such a prod­uct while work­ing in Tem­ple Street Chil­dren’s Hos­pi­tal in the 1990s test­ing ba­bies born with a lack of oxy­gen, some of which suf­fered brain dam­age as a re­sult of not get­ting treat­ment.

“The in­di­ca­tion is that 5 per 1,000 term ba­bies are wit­nessed clin­i­cally to have ex­pe­ri­enced oxy­gen de­pri­va­tion. But three times that num­ber of seizures oc­cur in the brain only with no-one to wit­ness them. Elec­troen­cephalog­ra­phy [EEG] is the only way to record brain ac­tiv­ity but it is a cum­ber­some test in­volv­ing 20 sen­sors that takes around two hours to set up.”

He got in touch with Pro­fes­sor Ger Boy­lan at the Irish Cen­tre for Fe­tal and Neona­tal Trans­la­tional Re­search (IN­FANT) in Cork whose team has been de­vel­op­ing an al­go­rithm which can de­tect ad­verse events in the brain and present data to doc­tors in use­ful terms.

“This tech­nol­ogy is the best of its kind in the world. I re­alised the mar­ket could ex­plode and the only other hin­drance to it that ex­isted was the fact that it takes two hours and a trained per­son to get the in­for­ma­tion in the first place through the EEG. I spoke with Ger who said no prod­uct ex­isted to ad­dress this prob­lem and I won­dered could I come up with some­thing.”

Hav­ing ap­proached En­ter­prise Ire­land with a loose con­cept, Jim went on the New Fron­tiers pro­gramme at In­sti­tute of Tech­nol­ogy Tal­laght and has raised €1.7m in ven­ture cap­i­tal fund­ing to de­velop the prod­uct, which now has US FDA ap­proval and should have CE cer­ti­fi­ca­tion for Europe next Jan­uary.

Jim also found a men­tor­ing pro­gramme run by Ibec group the Irish Med­i­cal De­vices As­so­ci­a­tion and En­ter­prise Ire­land ben­e­fi­cial.

“Incereb was for­tu­nate to have a very ex­pe­ri­enced and in­ter­na­tion­ally re­spected men­tor in John Power, founder of Aero­gen. His ad­vice to date has been crit­i­cal to the suc­cess of Incereb thus far and to the se­cur­ing of our first in­ter­na­tional dis­tri­bu­tion agree­ments,” he says.

Metabolomic Di­ag­nos­tics

Based in Lit­tle Is­land Co Cork on the site of a former Pfizer fa­cil­ity, Metabolomic Di­ag­nos­tics is well on the way to in­tro­duc­ing a rev­o­lu­tion­ary blood test which can pre­dict at 15 weeks whether a woman will de­velop preeclamp­sia later on in her preg­nancy.

Pro­fes­sor Louise Kenny of Univer­sity Col­lege Cork (UCC) and Pro­fes­sor Phil Baker of the Univer­sity of Le­ices­ter pi­o­neered the tech­nol­ogy be­hind Metabolomic Di­ag­nos­tics’ so­lu­tion.

With over 40 years’ com­bined ex­pe­ri­ence in the life sciences in­dus­try, the com­pany’s founders se­rial en­trepreneurs Charles Garvey, Diar­muid Ca­ha­lane and Paul Hands – had been look­ing for a tech­nol­ogy which could have rev­enue po­ten­tial in terms of be­com­ing a stan­dard of care for a par­tic­u­lar con­di­tion.

The pre-eclamp­sia screen­ing test fit­ted the bill and UCC agreed to li­cense the tech­nol­ogy to them to de­velop the prod­uct and con­tin­ues to col­lab­o­rate with the com­pany on it.

Ex­pe­ri­enced by about 5% of ex­pec­tant moth­ers, preeclamp­sia is the co-oc­cur­rence of high blood pres­sure and el­e­vated pro­tein in the urine lead­ing to re­stricted blood sup­ply to the foe­tus. Global re­search cited by Metabolomic Di­ag­nos­tics shows that it has been the most sig­nif­i­cant cause of ma­ter­nal death over re­cent decades and is re­spon­si­ble for around 20% of to­tal neona­tal in­ten­sive care costs.

“There is no cure for preeclamp­sia apart from an emer­gency Cae­sarean sec­tion, which can cre­ate high risks for the baby in par­tic­u­lar. At the mo­ment there is no means of pre­dict­ing preeclamp­sia,” ex­plains op­er­a­tions man­ager at the com­pany Hillary Cronin.

“Our sim­ple blood test in­volves the blood be­ing put into an in­stru­ment which in­di­cates whether the con­di­tion is present or about to be­come crit­i­cal. That in­stru­ment then up­loads the in­for­ma­tion into an al­go­rithm we’ve de­vel­oped which can es­tab­lish the chances of the woman de­vel­op­ing it later.”

Ca­ha­lane adds: “Our low-risk preeclamp­sia test is now part of an EU-wide study of 5,000 women to an­a­lyse its ef­fi­cacy and we ex­pect to in­tro­duce it at the start of 2017. There is al­ready huge in­ter­est in it from health­care providers in the US and Europe.”

Eric Reed, non-ex­ec­u­tive di­rec­tor of Sur­gaColl Tech­nolo­gies, John Glee­son, CEO of Sur­gaColl Tech­nolo­gies and Dr Caro­line Curtin, post­doc­toral re­searcher with the Tis­sue En­gi­neer­ing Re­search Group (TERG) in RCSI

The Neon de­vice de­vel­oped by Incereb

Bill Liao, SOS Ven­tures, Frank Walsh, En­ter­prise Eq­uity AIB Seed Cap­i­tal Fund, Charles Garvey co­founder and CEO of Metabolomic Di­ag­nos­tics and Diar­muid Ca­ha­lane, co-founder and reg­u­la­tory af­fairs di­rec­tor, Metabolomic Di­ag­nos­tics

Embo Med­i­cal co-founders Wayne Allen, Colin Forde and Liam Mullins

Dr Brian Thornes, founder of

X-Bolt Or­thopaedics

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