Five Things in 2018 That Shook Our World — of Healthcare 3D Printing and Bioprinting

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(Orignially published on “Two Cents” by Jenny Chen, M.D.)

This year 3DHEALS have organized about 38 local and global events and shared more than 550+pieces of news on social media, and more than 1400+ photos and videos about our universe on Instagram. Out of all these, 3DHEALS team has picked the following news in 2018 to be revisited.

1. Love and hate relationship between Align Technology and Smile Direct Club: The giant in the clear aligner industry is seeing a little slow down recent months, and some speculate that a rising competitor Smile Direct Club (SDC), a company focusing on at-home clear aligner market, could contribute to that slowdown. However, Align Tech. acquired ownership of 19% of SDC in 2016. However, the pair appears to be in disputes this year, especially in terms of new Invisalign stores that SDC considered a breach of a non-compete clause. Currently, the cost of SDC is 60% less to the consumers, and largely due to a decentralized care strategy using teledentistry. Its effectiveness is not yet widely accepted, especially among dental professionals. Some even spoke out against DIY solutions. While being cautious is important in healthcare, the paranoid side of me thinks the tendency of healthcare professional’s job insecurity could play a role in slowing down the progress towards a decentralized, cheaper, and high-quality care many outside of the industry have.

2. United Therapeutics marches forward with its lung transplant ambition: Following last year’s new partnership with 3D Systems on scaffold development, the Maryland biotech’s organ manufacturing and transplantation subsidiary, Lung Biotechnology PBC, strike another deal with Isreal-based CollPlant and obtained an exclusive license to CollPlant’s recombinant human collagen (rhCollagen) and its Bioink. The license agreement is not limited to lung tissues only. With the clock ticking for many desperate patients on the transplant list, bigger players like UT leading the way give the patients a thread of hope.

3. Two words: Digital Dentistry (3D Systems, Stratasys, Carbon): Digital dentistry is forecasted to be around 37 billion dollars in 2021, and 3D printing will be at least 2.5% of that. I don’t believe in the forecast, but I know how many dentists and dental labs post daily on Instagram about #dental3dprinting and #digitaldentistry daily. In 2018, Carbon, 3D Systems, Stratasys all tapped into the dental market. 3D Printing industry is finally waking up to the fact that the dental market is the next frontier for growth in the healthcare sector, after 20 years of Align Technology success story! Earlier this year both 3D Systems and Stratasys announced new solutions to the dental market, offering not just new printers but materials and services surrounding the solutions. Later, Carbon announced its partnership with the largest dental lab network National Dentex Lab, after receiving FDA clearance of two class II materials, DENTCA Denture Base II and DENTCA Denture Teeth. As predicted by many, the final winner may be dictated by the success of consumables and not the printers, and behind that smart partnership and business strategies.

4. Regulatory Landscape: Wins and Fights. After FDA published its finalized version of its guidance for 3D printed medical device in 2017, Australia (TGA), China (CFDA), Canada also voiced their views on the subject in 2018 and are actively soliciting feedback from the public. However, just as countries and organizations continue to struggle with regulating emerging technology, in November, FDA Commissioner Dr. Scott Gottliebandannounced the modernization of the 510(k)-clearance pathway, limiting comparison to predicates less than 10 years old. The impact of this new law on healthcare 3D printing is still out. Interested parties can follow 3DHEALS blog “Expert’s Corner” on the subject in near future. Despite the muddy waters on the regulatory fronts, those who are determined had been a few “wins”:

a. Materialise became the first company to receive FDA clearance for diagnostic 3D-printed anatomical models for its Mimics inPrint software in March this year. Later in September, South Korean Ministry of Food and Drug Safety (MFDS) licensed the medical use of 3D planning software Mimics Medical and ProPlan CMF.

b. In September, the American Medical Association (AMA) CPT® Editorial Panel accepted the proposal led by the American College of Radiology (ACR) for 3D anatomic modeling. The new Category III codes will be effective July 1, 2019.

5. Fundraising: (It is likely the following list is incomplete, however, you can add any interesting startups to our 3DHEALS company directory.)

Some notable rounds in the healthcare 3D printing and bioprinting startup world include the following:

a. Biomodex raised added $15 million to its Series A funding round, bringing the total raised to $18.5 million to support its patient-specific 3D-printed synthetic organ platform designed for pre-operative planning.

b. Cellink, a Swedish bioprinting company, received a €2.5 million EU grant for the development and commercializing of its TumorPrint project.

c. Prellis Biologics, a bioprinting startup focusing on laser-based printing technology and aiming to overcome the vascularization challenge in bioprinting, raised an undisclosed amount from Plug and Play, and a few other investors this year.

d. Standard Cyborg , raised $2.4 million this year and pivoted to 3D Scanning API from software for 3D printed prosthetics.

e. Pandorum Technologies, a human organ on demand startup, raised $3.6 million this year from a series A round from Indian Angel Network Fund, 021 Capital, 500 Startups and the Karnataka government backed Karnataka Information Technology Venture Capital (KITVEN) fund. It’s the first startup to bioprinting Indian’s first artificial liver tissue.

f. Poietis, a bioprinting startup in France, completed fundraising of €5 million this year. Currently, Poietis aims to use its laser-based bioprinting technologies to produce implantable skin, but possibly other tissues in the longer term.

g. OxSyBio, a bioprinting startup based in London, United Kingdom, raised £10M this year, completing its series A round.

Happy 2019!