Annual report pursuant to Section 13 and 15(d)

Commitments and Contingencies (Details)

v3.20.1
Commitments and Contingencies (Details) - USD ($)
1 Months Ended 12 Months Ended
Jan. 31, 2019
Dec. 31, 2019
Other Commitments [Line Items]    
Audit committee findings   The primary investigative findings were: (i) the DABRA catheter frequently failed to calibrate and occasionally overheated, posing a risk of injury to physicians and patients; (ii) the Company’s explanations regarding its fourth quarter 2018 and first quarter 2019 sales created a risk of confusion because they did not explicitly reference inconsistent DABRA catheter performance and catheter failures; (iii) the Company failed to timely make at least two Medical Device Reports, or MDRs, to the FDA; (iv) the Company, out of a concern for the DABRA catheters’ performance, engaged in systematic efforts to replace product held by customers, which constituted product recalls, but were not documented as such, (v) the Company lack documentation of sufficient detail and specificity to support certain payments to physicians, ostensibly for training and consulting services, and as to three physicians did not accurately reflect the purpose and nature of approximately $300,000 of payments, which could be perceived as an improper attempt to obtain business or to gain special advantage, (vi) while the indication for use in the 510(k) clearance the Company obtained for the DABRA system is not for atherectomy, the Company’s salespeople were instructed to characterize DABRA as performing atherectomy and to encourage doctors to seek reimbursement using atherectomy codes, (vii) the Company’s determinations to direct potentially valuable benefits and opportunities to doctors were informed in part by sales prospects, and (viii) the Company received complaints regarding regulatory or compliance concerns that, because they implicated executive officers, should have been brought to the attention of the Board or the Audit Committee, but were not.
Payments to physicians that lack documentation of sufficient detail   $ 300,000
Retirement benefits, description   In January 2019, the Company established a defined contribution plan under Section 401(k) of the Internal Revenue Code (“401(k) Plan”) that the Company administers for participating employees’ contributions.
Defined contribution plan, description   All full-time employees are eligible under the 401(k) Plan. The Company will make contributions, based on a match of 100% of each employee’s contribution up to 3% and 50% of contributions between 3% and 5%, with the match-eligible contribution being limited to 4% of the employee’s eligible compensation.
Defined benefit contribution plan expense   $ 300,000
First Anniversary [Member]    
Other Commitments [Line Items]    
Employer matching contribution, maximum (percentage) 100.00%  
Maximum contribution per employee (percentage) 3.00%  
Second Anniversary [Member]    
Other Commitments [Line Items]    
Employer matching contribution, maximum (percentage) 50.00%  
Third Anniversary [Member]    
Other Commitments [Line Items]    
Maximum contribution per employee (percentage) 4.00%  
Minimum [Member] | Second Anniversary [Member]    
Other Commitments [Line Items]    
Maximum contribution per employee (percentage) 3.00%  
Maximum [Member] | Second Anniversary [Member]    
Other Commitments [Line Items]    
Maximum contribution per employee (percentage) 5.00%