" In­dia is an ex­tremely vi­able grow­ing mar­ket for ex­pan­sion" Wayne Paterson, CEO, Adme­dus

BioSpectrum (Asia) - - Front Page -

Aus­tralian Med­i­cal Tech­nol­ogy firm Adme­dus fo­cusses on de­vel­op­ing and in­no­vat­ing next gen­er­a­tion med­i­cal tech­nolo­gies in car­dio­vas­cu­lar space. Its lead prod­uct Car­dioCel is based on its pro­pri­etary ADAPT tech­nol­ogy. Car­dioCel, is cur­rently be­ing used by sur­geons in more than 135 global cen­tres in Australia, Europe, US, Canada, Singapore, Malaysia, Hong Kong, Mid­dle East and North Africa Re­gion. Pri­mar­ily used in restora­tive struc­tural heart re­pair and re­con­struc­tion, ADAPT treated tis­sue pro­vides un­par­al­leled re­sis­tance to cal­ci­fi­ca­tion, de­liv­er­ing trans­for­ma­tive re­pair with longterm dura­bil­ity that en­ables na­tive cells to suc­cess­fully grow and dif­fer­en­ti­ate through the en­tire re­pair, with­out cal­ci­fi­ca­tion or tox­i­c­ity. In part­ner­ship with Syn­cronei Med­i­cal In­dia, Adme­dus re­cently launched its ADAPT tech­nol­ogy and its flag­ship prod­uct Car­dioCel in In­dia. Speak­ing to BioSpec­trum Asia, Wayne Paterson, CEO, Adme­dus, dis­cusses the op­por­tu­ni­ties and chal­lenges for Car­dioCel in the In­dian mar­ket.

Edited ex­perts:

What are your key ini­tia­tives for the In­dian mar­ket for the next few years?

In a mar­ket that en­com­passes a rapidly grow­ing health­care seg­ment worth $158 bil­lion, over 50 mil­lion car­diac pa­tients and an av­er­age 280,000 babies born with a Con­gen­i­tal Heart De­fect (CHD) - In­dia is an ex­tremely vi­able grow­ing mar­ket for ex­pan­sion. It is for this rea­son that Adme­dus has un­der­taken a dis­tri­bu­tion part­ner­ship with Syn­cronei Med­i­cal, based on their cred­i­bil­ity and ex­pe­ri­ence in the In­dian re­gen­er­a­tive tech­nol­ogy and sur­gi­cal sec­tors. Their ex­per­tise in a geo­graphic re­gion such as In­dia, will be fun­da­men­tal in en­sur­ing Car­dioCelis ef­fec­tively launched and prop­erly po­si­tioned in this ma­jor emerging mar­ket.

What are the ma­jor chal­lenges you fore­see in com­mer­cial­iz­ing/launch­ing Car­dioCel in the In­dian mar­ket?

Like any emerging mar­ket, In­dia has some chal­lenges with pa­tient ac­cess and prod­uct dis­tri­bu­tion chan­nels. Price is def­i­nitely a more volatile driver in emerging mar­kets as sub-dis­trib­u­tors and health­care fa­cil­i­ties can be op­por­tunis­tic in the way they struc­ture their charges to pa­tients. This is a po­ten­tial con­cern for com­pa­nies do­ing busi­ness in In­dia where man­u­fac­tur­ers main­tain a very low mar­gin but pa­tients still end up pay­ing a higher price. Com­pany mar­gins can be as low as 10 per cent on ma­jor prod­ucts in In­dia with mul­ti­ple steps in the sup­ply chain typ­i­cally tak­ing 25-30 per cent mar­gin at each level.

Com­pa­nies sup­ply­ing prod­uct to these mar­kets who ex­pe­ri­ence this have limited in­flu­ence over the mar­ket price as the prod­uct gets fur­ther away from the com­pany’s con­trol in the dis­tri­bu­tion chan­nel. Our strat­egy is to demon­strate the value of the Car­dioCel tech­nol­ogy to In­dian sur­geons through our part­ner­ship with Syn­cronei Med­i­cal, whose net­work of con­nec­tions with Key Opin­ion Lead­ers (KOLs) will be paramount to our suc­cess in the re­gion. To sup­port the launch of Car­dioCel in In­dia, ADAPT in­ven­tor and Adme­dus Vice Pres­i­dent of Car­dio­vas­cu­lar Tech­nolo­gies Prof Leon Neeth­ling de­liv­ered a com­pre­hen­sive se­ries of meet­ings and pre­sen­ta­tions with physi­cians in ma­jor health cen­tres across In­dia to demon­strate the prod­uct’s clinical ap­pli­ca­tions and ben­e­fits. Adme­dus and Syn­cronei Med­i­cal are look­ing for­ward to work­ing closely with In­dian clin­i­cians, health of­fi­cials and KOLs to build pro­duc­tive long-term re­la­tion­ships fo­cused on help­ing to im­prove the health out­comes and qual­ity of life for In­dian pa­tients with heart dis­ease.

Glob­ally which are the other emerging mar­kets that you plan­ning to tar­get for launch­ing Car­dioCel?

Emerging mar­kets is a key fo­cus area for Adme­dus as we look to de­liver our clin­i­cally su­pe­rior prod­ucts into re­gions that have large pop­u­la­tions and a high in­ci­dence rates of car­dio­vas­cu­lar dis­ease. We re­cently launched our Car­dioCel 3D prod­uct in the US and Canada and sell our prod­ucts in the Mid­dle East and North Africa (MENA) re­gion via a part­ner­ship. We’re cur­rently pur­su­ing op­por­tu­ni­ties for reg­u­la­tory ap­proval in China, Turkey, Mexico and Australia.

Car­dioCel is al­ready mar­keted in North Amer­ica and Europe. In com­par­i­son to Amer­i­can and EU mar­kets, how do you see Asia’s mar­ket for Car­dioCel?

China and In­dia rep­re­sent mar­ket ter­ri­to­ries with enor­mous po­ten­tial for Adme­dus to lever­age as the dis­ease in­ci­dence and preva­lence in Asia is on par or higher than the US and EU depend­ing on the in­di­ca­tion. From a reg­u­la­tory per­spec­tive, US FDA and EU ap­proval, both es­tab­lish a com­pre­hen­sive stan­dard of health­care for world­wide reg­u­la­tion – one that has given Adme­dus a foun­da­tion un­der­stand­ing for our or­gan­i­sa­tion’s ap­proach to gain­ing reg­u­la­tory ap­proval across the re­gion, and the value of lo­cal ex­pert con­sul­tan­cies in achiev­ing ap­proval. We are con­tin­u­ing to work through the process for TGA ap­proval in Australia which is our home mar­ket and rep­re­sents an enor­mous op­por­tu­nity for Adme­dus. We are hop­ing to se­cure a pos­i­tive out­come in this mar­ket dur­ing 2018 and this will def­i­nitely open doors to our Asia-Pa­cific neigh­bours. Sheer pop­u­la­tion size is the main rea­son the Asian mar­kets is so valu­able to Adme­dus as the in­ci­dence rates of con­gen­i­tal heart dis­ease, heart de­fects and car­dio­vas­cu­lar dis­ease in­crease steadily with pop­u­la­tion growth. We see a sig­nif­i­cant op­por­tu­nity for pa­tients to ben­e­fit from our unique and clin­i­cally su­pe­rior prod­ucts in the com­ing years.

Please throw some light on your ex­pan­sion plans.

Adme­dus is listed on the Aus­tralian Stock Ex­change and cur­rently has oper­a­tions across the US, EU and Emerging mar­kets with cor­po­rate ser­vices and bioman­u­fac­tur­ing based in Australia. We are look­ing to grow rev­enues by 60 per cent in 2018 largely due to in­creased uti­liza­tion of the prod­ucts in all ter­ri­to­ries but par­tic­u­larly in the US where we just signed a pur­chas­ing agree­ment with a ma­jor Group Pur­chas­ing Or­gan­i­sa­tion. Se­cur­ing reg­u­la­tory ap­proval in Australia is a ma­jor pri­or­ity and will help to progress our ex­pan­sion plans in other emerging mar­kets. We are also rapidly ex­pand­ing our prod­uct port­fo­lio and are bring­ing to mar­ket high value 3D moulded sur­gi­cal col­la­gen so­lu­tions in ar­eas with high un­met med­i­cal needs.

What ac­cord­ing to you are some of the key trends driv­ing your busi­ness in Asia?

As we op­er­ate in the Car­dio­vas­cu­lar space we see sim­i­lar trends in Asia as other parts of the world, namely that chang­ing lifestyles and diet are lead­ing to a higher in­ci­dence and preva­lence of car­dio­vas­cu­lar dis­ease which re­quire in­ter­ven­tion. Se­condly, pop­u­la­tion trends through birth rate and age­ing, sig­nif­i­cantly in­creases the in­ci­dence of car­dio­vas­cu­lar dis­ease which opens a huge po­ten­tial mar­ket for our prod­ucts. As such, Adme­dus’ plans to move up the value chain with the en­tire plat­form of ADAPT prod­ucts in a mas­sive mar­ket where we can scale for long-term suc­cess.

Emerging mar­kets such as In­dia and China are also de­vel­op­ing rapidly and grow­ing af­flu­ence in these re­gions means more peo­ple are look­ing for the best op­tions in health care, for them­selves, their pa­tients and their chil­dren and Adme­dus ADAPT prod­ucts are the best in the world. Pa­tients now have more ac­cess to in­for­ma­tion on the treat­ment op­tions and prod­uct avail­able in other parts of the world and this will help to drive de­mand and ex­pec­ta­tion for health­care providers in these re­gions to of­fer high qual­ity and in­no­va­tive health so­lu­tions.

Lack of har­mo­niza­tion makes reg­u­la­tory ap­proval for medtech prod­ucts dif­fi­cult in Asia. Please elab­o­rate on reg­u­la­tory hur­dles in Asia’s medtech space.

The main chal­lenge to reg­u­la­tory ap­proval in Asia is that each re­gion has its own sys­tems, pro­cesses and reg­u­la­tory re­quire­ments. For example, some mar­kets rely on CE, FDA or TGA ap­provals while other mar­kets such as China and Ja­pan gen­er­ally re­quire reg­is­tra­tion stud­ies. There is an ab­sence of mean­ing­ful col­lab­o­ra­tion across health sys­tems in Asia so each coun­try is a new ap­pli­ca­tion and process to nav­i­gate which can be ex­pen­sive and time con­sum­ing. For­eign com­pa­nies need to seek out a clear un­der­stand­ing of the reg­u­la­tory and re­im­burse­ment path­ways, and stay up-to-date on changes. It would be ben­e­fi­cial to pa­tients in the re­gion if we could adopt an EU type of ap­proach whereby reg­is­tra­tion is granted across the re­gion. This would ac­cel­er­ate time to mar­ket and al­low pa­tients to have ac­cess to life sav­ing treat­ments.

Aish­warya Venkatesh aish­warya.venkatesh@mmac­tiv.com

Wayne Paterson,CEO, Adme­dus«

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