Maculus Therapeutix has developed an easy to apply, biodegradable hemostasis device, MacuBloc™, for use following nasal polyp surgery. The company has de-risked the technology and the regulatory 510(k) class 1 clearance from FDA and is expected to be revenue generating in 12 months with about 80% gross margins. Current post-polyp surgery products for hemostasis involve solid nasal packing, which causes extreme headaches; blocks nasal passages and patients experience difficulty with nasal breathing. The subsequent removal of nasal packing requires a separate office visit and also causes re-bleeding during the packing removal. About 815K nasal polyps surgeries performed in the US (2.1M globally) annually with a US market opportunity of ~ $500M for the packing materials alone, which is expected to reach $700M+ by 2024. Maculus has completed the R&D phase of product development and the in vitro and in vivo safety studies using small animal models. Maculus has submitted the pre-submission...
Maculus Therapeutix has developed an easy to apply, biodegradable hemostasis device, MacuBloc™, for use following nasal polyp surgery. The company has de-risked the technology and the regulatory 510(k) class 1 clearance from FDA and is expected to be revenue generating in 12 months with about 80% gross margins. Current post-polyp surgery products for hemostasis involve solid nasal packing, which causes extreme headaches; blocks nasal passages and patients experience difficulty with nasal breathing. The subsequent removal of nasal packing requires a separate office visit and also causes re-bleeding during the packing removal. About 815K nasal polyps surgeries performed in the US (2.1M globally) annually with a US market opportunity of ~ $500M for the packing materials alone, which is expected to reach $700M+ by 2024. Maculus has completed the R&D phase of product development and the in vitro and in vivo safety studies using small animal models. Maculus has submitted the pre-submission to FDA for MacuBloc™ 510(k) clearance. FDA has agreed to classification of the device at 510(k) class I and agreed with the testing plans to get the clearance.
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Syed Askari
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Syed Askari CEO Syed is serial Entrepreneur and is over 25 years medical device veteran, also founded / exited Medicus Biosciences, has over 25 patents