Making an OEM

“We will become the largest global player in secondary screening and diagnostics for women with dense breasts. . .”

SmartBreast CEO, Dr. James Hugg, on his MBI startup’s big goals.


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The Imaging Wire


Making an MBI OEM

SmartBreast continued to acquire and partner its way to Molecular Breast Imaging (MBI) leadership this week, buying GE Healthcare’s MBI assets and signing a MBI manufacturing deal with FoxSemicon. SmartBreast might not be a household name and MBI might not be a mainstream modality, but this is turning into a really interesting story.

  • The FoxSemicon Deal – One day after the GE deal, SmartBreast announced an alliance with FoxSemicon Integrated Technologies (FITI, a Foxconn subsidiary) that includes a “substantial” investment, contract manufacturing, and co-development of its future MBI systems.
  • About SmartBreast – SmartBreast has a two-person workforce (at least according to LinkedIn), which isn’t what you’d expect to see from a company that just took an entire modality off of GE’s hands. However, SmartBreast and its parent company EVO WorldWide have deep MBI ties (EVO previously sold GE MBIs in Asia, company execs are MBI/CZT/SPECT veterans) and SmartBreast has a really big goal to make MBI the go-to modality for women with dense breasts.
  • Up Next – With SmartBreast’s MBI acquisitions complete and its manufacturing plan in place, the company is now working on a $5m seed round that it will use to “become the largest global player in secondary screening and diagnostics for women with dense breasts.”

The Wire

  • Echo AI Mortality Predictor: A Geisinger team developed an echocardiogram-based machine learning system that can accurately predict patients’ one-year all-cause mortality, calling it a milestone for AI trained on unstructured data (videos). The model (trained w/ 812k echos, 34k patients) predicted 2,404 patients’ mortality outcomes more accurately than the Seattle Heart Failure score and a separate EHR-based model, while improving cardiologists’ mortality prediction sensitivity by 13% without affecting specificity.
  • Hyperfine’s $90M: Point-of-care MRI startup Hyperfine Research just closed a $90M Series D round that it will use to “aggressively scale-up” the Swoop portable MR’s commercial expansion and fund ongoing product development. That’s a big number, but Hyperfine (a Butterfly Network sibling company) also has big plans to democratize MRI.
  • Huami’s Imaging Push: Chinese smartwatch giant Huami continued its expansion into the medical arena, contributing $5m to Hyperfine’s $90m Series D round (see above), just a few weeks after investing in PoC MRI rival Promaxo, and about six months after signing a product development and marketing partnership with X-ray manufacturer Aspen Imaging Healthcare that “could lead to an investment.” Huami has always focused on consumer wellness, but the company’s recent moves definitely suggest a new focus on medical imaging (two portable MRI investments in a month is more than a coincidence).
  • Appendicitis Imaging’s Mixed CDS Results: A Children’s Minnesota Hospital-based research team found that a custom pediatric appendicitis CDS solution (estimates appendicitis risk at EHR, makes imaging recommendations) didn’t actually reduce emergency ultrasound or CT volumes. The researchers randomly assigned 17 hospital EDs to either use their CDS software or follow standard procedures (n = 3,161 patients w/ CDS, 2,779 w/o CDS), finding no statistical difference in imaging utilization or outcomes (e.g. missed appendicitis, negative appendectomies, costs) between the two groups. However, one 11-hospital system in the study reduced all imaging use among patients with <15% risk of appendicitis and reduced CT use among patients with 15% to 50% risk of appendicitis.
  • Envision’s ESOP Suit: A former Envision Radiology MRI/CT technologist filed a class action lawsuit against the Colorado-based practice (36 imaging centers, 1k employees) for allegedly taking advantage of employees when it rolled out its employee stock ownership plan. The lawsuit claims that when Envision’s management sold their shares to company employees for $164m they: 1) Significantly overvalued the company; 2) Didn’t allow employees to negotiate; 3) Required the ESOP to take on $154m in debt to finance the deal; 4) Still retained all control of the company.
  • Follow-up Variations: A new Brigham and Women’s Hospital study revealed wide variations in pulmonary nodule follow-up recommendations. The researchers reviewed 24.5k chest and abdominal CT reports with pulmonary nodules, finding follow-up recommendations in 4.9k reports (20.1%) and revealing an up to 4.3-fold difference in recommendation probability when comparing radiologists within the same subspecialty divisions.
  • Signify on Teleradiology: New Signify Research analysis published on auntminnie.com shared an optimistic view of the global teleradiology market after a difficult 2020, due in part to advances in AI-integrated teleradiology (and presumably a post-COVID volume rebound). The firm also forecast that: 1) Many telerad practices will gradually shift to more standard off-the-shelf imaging IT products, and away from self-developed imaging IT; 2) As a result, telerad practices’ overall IT costs will decline; 3) Teleradiology practices M&A will continue, but the segment will remain fragmented.
  • OXOS Democratizing X-Ray: OXOS Medical’s flagship Micro C Medical Imaging System recently gained FDA approval, paving the way for the unique handheld X-ray system’s commercial launch. OXOS historically positioned the Micro C as a surgery guidance solution for extremities, but now touts it as a “democratized” diagnostic X-ray solution for settings that aren’t size/cost-relevant for traditional X-ray (e.g. nursing homes, urgent care, home health, and sports medicine practices).
  • A Case for Screening at 40: A new MD Anderson study supports the cost effectiveness of starting breast cancer screening at the age of 40 to assess density, followed by a density-tailored screening approach (dense = annual screenings from 40-75yrs; non-dense = biennial from 50-75yrs). Using a microsimulation model, the study found that this density-based screening approach came with an additional $36k in screening costs per quality-adjusted life-years compared to the current standard (dense & non-dense = biennial 50-75yrs), which is well below society’s $100k/QALY benchmark.
  • Vuno IPO: South Korean imaging AI developer, Vuno, announced plans to IPO on the Kosdaq stock exchange and use the $24m-$31m in new capital to “leap from a top AI-based medical device company in Korea to a global player.” Specifically, Vuno plans to expand overseas through partnerships with global healthcare companies and medical institutions and expand its AI product pipeline.
  • COVID’s MRI Impact: A new survey from IMV Medical revealed that the COVID-19 pandemic drove a 35% reduction in U.S. MRI exam volumes in 2020 (to ~27.4m exams). The report highlighted a massive drop in monthly MRI volumes in April 2020 (1.42m vs. 2.79m in Jan 2020) and estimated that monthly MRI volumes rebounded to 2.28m later in the year (still below pre-COVID levels).
  • Flosonics’ Wearable Ultrasound Funding: Flosonics Medical closed a $14m round that it will use to develop and commercialize its FloPatch wearable ultrasound device. FloPatch adheres to a patient’s neck, performing on-demand Doppler blood flow measurements during clinical interventions in the ED, OR, or ICU. This might not be our type of imaging, but it’s a good example of wearable ultrasound’s potential to expand across clinical applications and departments.
  • AVC DL: A South Korean team developed a cardiac CT deep learning algorithm that’s able to accurately detect and quantify aortic valve calcium (AVC). The model (trained w/452 CTs, tested w/ 137 separate CTs) detected 98.5% of patients with AVC and determined these patients’ AVC volume grades with 97% accuracy (vs. four radiologists’ 69.7% to 91.9% accuracy), specifically outperforming radiologists when grading severe AVC.
  • SyntheticMR AB & United Imaging: SyntheticMR AB announced a license agreement with United Imaging, allowing UIH to sell SyntheticMR’s SyMRI NEURO MRI solution package globally (provides multiple contrast images, tissue volumes, myelin-correlated volumes, and quantitative data). The partnership expands United Imaging’s MRI solutions portfolio while giving SyntheticMR even wider MRI market coverage (SyntheticMR already partners w/ GE, Siemens, and Philips).

The Resource Wire

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